[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-dysfunction-associated-steatotic-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-dysfunction-associated-steatotic-liver-disease":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,56,90,118,158,195,224,256,300,329,359,379,401,429,453,485,532,564,590,618,643,669,696,725,747],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100605631","phase-3-a-master-protocol-of-multiple-agents-in-adults-with-metabolic-dysfunction-associated-steatotic-liver-disease-synergy-outcomes-100605631",false,"NCT07165028","A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)","A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes","Inclusion Criteria:\n\n* Have liver fat content ≥8%\n* Have ELF score of ≥9 and ≤10.8 at screening\n* Have VCTE LSM ≥10 kilopascal (kPa) and \\\u003C20 kPa at screening\n\nExclusion Criteria:\n\n* Have any other type of liver disease other than MASLD\n* Have a body mass index (BMI) \\\u003C25 kilogram per square meter (kg\u002Fm2)\n* Prior decompensated liver disease (history of esophageal\u002Fgastric varices, ascites, hepatic encephalopathy)\n* Have lost more than 11 pounds within the 3 months prior to screening\n* Have a hemoglobin A1c (HbA1c) greater than 10%\n* Have type 1 diabetes","ALL","18 Years",{"count":20,"type":21},4500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression.\n\nOnce the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.",[27],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Nonalcoholic Steatohepatitis","NASH","Fatty Liver","Fatty Liver Disease","SLD","Metabolic Dysfunction-Associated Fatty Liver Disease","MAFLD","Non-alcoholic Fatty Liver Disease","NAFLD","Hepatic Steatosis","Liver Related Outcomes","GLP1","Incretin","Non-Invasive Test","RECRUITING","2026-08-20",{"date":46,"type":47},"2026-08-21","ACTUAL",{"date":49,"type":47},"2025-10-15",{"date":51,"type":21},"2032-08",{"name":53,"class":54},"Eli Lilly and Company","INDUSTRY",565,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100652818","metformin-dapagliflozin-effects-on-igf-1-in-male-t2dm-with-masld-100652818","NCT07778719","Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD","Effects of Metformin Combined With Dapagliflozin on Serum IGF-1 Levels in Male Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease","MDEITM","Inclusion Criteria:\n\n1. Males aged 30-60 years;\n2. Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%;\n3. Having received a stable dose of metformin (≥1500 mg\u002Fday or the maximum tolerated dose) as monotherapy for at least 8 weeks;\n4. Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB\u002Fm detected, with the presence of at least one cardiometabolic risk factor;\n5. No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists;\n6. Willing to participate voluntarily and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus or other specific types of diabetes;\n2. Weekly alcohol intake exceeding 210g for males;\n3. Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);\n4. Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;\n5. Previous or current use of GH preparations or IGF-1 preparations;\n6. Baseline estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m²;\n7. Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis);\n8. Active malignant tumors;\n9. Allergy to dapagliflozin or similar drugs;\n10. Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months;\n11. Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.","MALE","30 Years","60 Years",{"count":68,"type":21},84,[70],"NA","This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB\u002Fm, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg\u002Fday for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.",[73,27],"Type 2 Diabetes",[75,76,77,78,27],"Dapagliflozin","Metformin","Serum IGF-1","Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2026-08-19",{"date":46,"type":47},{"date":83,"type":21},"2026-10-01",{"date":85,"type":21},"2027-12-11",{"name":87,"class":88},"The 95th Hospital of Putian，Putian, Fujian, China","OTHER",1,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100646438","a-study-to-estimate-secukinumab-retention-rate-in-psoriasis-patients-with-masld-100646438","NCT07683065","A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD","SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD","SEC-HOPE","Inclusion criteria:\n\n* Patients with a first recorded secukinumab prescription between 01 January 2021 and 31 December 2023.\n* Patients aged ≥18 years at index date.\n* Patients with no prior secukinumab exposure in available EMR history.\n* Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis\u002Fpsoriatic arthritis (PsA).\n* Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC).\n* Patients with confirmed plaque psoriasis with or without PsA.\n* Patients with at least one cardiometabolic risk factor.\n* Patients with a confirmed MASLD diagnosis.\n* Patients with baseline laboratory data available.\n\nExclusion criteria:\n\n* Patients with evidence of MASLD absence.\n* Patients with malignant liver disease.\n* Patients with a history of liver transplantation.\n* Patients with alcohol use disorder.\n* Patients with other chronic liver diseases.\n* Patients with diseases or treatments which cause thrombocytopenia.\n* Patients with decompensated cirrhosis.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":100,"type":21},150,"OBSERVATIONAL","This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis \\[PsA\\]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.",[104,27],"Plaque Psoriasis",[106,107],"Plaque psoriasis","MASLD Hepatic Biomarkers Trajectories","2026-08-13",{"date":110,"type":47},"2026-08-14",{"date":112,"type":47},"2026-07-08",{"date":114,"type":21},"2027-01-15",{"name":116,"class":54},"Novartis Pharmaceuticals",4,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":101,"phases":4,"briefSummary":129,"conditions":130,"keywords":135,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100651885","prospective-evaluation-of-hepatocellular-carcinoma-surveillance-in-at-risk-patients-screening-hcc-100651885","NCT07764835","Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)","Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients Using Semiannual Ultrasound LI-RADS and Alpha-Fetoprotein: A Multicenter Real-World Observational Study","Screening HCC","Inclusion Criteria:\n\n* Written informed consent.\n* Age 18 years or older.\n* Liver cirrhosis of any etiology.\n* Chronic hepatitis B with moderate or high risk of HCC according to PAGE-B criteria.\n* Non-cirrhotic chronic liver disease with increased risk for HCC, including fibrosis stage 3 or higher or metabolic dysfunction-associated steatotic liver disease (MASLD) with one or more risk factors for HCC.\n* Followed at hepatology clinics within the Rede D'Or health network.\n* Eligible for routine HCC surveillance with ultrasound and alpha-fetoprotein according to standard clinical practice.\n\nExclusion Criteria:\n\n* Known hepatocellular carcinoma at enrollment.\n* Previous diagnosis of hepatocellular carcinoma.\n* Metastatic liver disease.\n* Other malignant liver tumors present at enrollment.\n* Clinical condition preventing routine surveillance follow-up.\n* Inability to provide informed consent.",{"count":127,"type":21},300,"36 Months","This prospective multicenter observational study evaluates the performance of a structured hepatocellular carcinoma (HCC) surveillance program in patients at increased risk of developing liver cancer. Participants will undergo routine surveillance with semiannual abdominal ultrasound reported using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS) and serum alpha-fetoprotein (AFP) testing as part of standard clinical care. The study aims to assess HCC detection rates, stage at diagnosis, detection of other hepatic malignancies, and the time intervals between detection, diagnosis, and treatment in a real-world setting. Approximately 300 participants will be enrolled and followed for up to 36 months.",[131,132,133,27,134],"Hepatocellular Carcinoma","Liver Cirrhosis","Chronic Hepatitis B","Advanced Liver Fibrosis",[136,131,137,138,139,140,141,142,132,133,143,27,144,145,146,147,148,149],"HCC","Liver Cancer","HCC Surveillance","US LI-RADS","Ultrasound LI-RADS","Alpha-Fetoprotein","AFP","MASLD","Real-World Study","Observational Study","Early Detection","BCLC","Rede D'Or","Brazil","2026-08-10",{"date":110,"type":47},{"date":153,"type":21},"2026-09-15",{"date":155,"type":21},"2029-06-30",{"name":157,"class":88},"D'Or Institute for Research and Education",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":143,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100651335","metabolic-flux-analysis-in-metabolic-dysfunction-associated-steatotic-liver-disease-100651335","NCT07760909","Metabolic Flux Analysis in Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Flux Analysis in MASLD","Inclusion Criteria:\n\n* Scheduled and clinically cleared for protocol-eligible bariatric surgery at Vanderbilt University Medical Center.\n* BMI ≥40 kg\u002Fm², or BMI \\>35 kg\u002Fm² with at least one obesity-associated comorbidity, such as type 2 diabetes, cardiovascular disease, hypertension, hyperlipidemia, obstructive sleep apnea, MASLD, osteoarthritis, or polycystic ovarian syndrome.\n* Able and willing to complete study procedures, including informed consent, questionnaires, blood draws, MRI\u002FMRE imaging, stable isotope tracer infusion, and research tissue collection during planned bariatric surgery.\n* Able to provide informed consent in English.\n\nExclusion Criteria:\n\n* Contraindication to MRI\u002FMRE, including implanted cardiac defibrillator, pacemaker, or other MRI-incompatible implanted device.\n* Prior gastric or intestinal surgery, pancreatic surgery, or other prior surgery that, in the judgment of the study team or bariatric surgeon, would interfere with study procedures or outcome interpretation.\n* Active cancer or ongoing cancer treatment.\n* Presence or history of HIV infection.\n* Alcohol use above study-defined limits: more than 14 alcoholic drinks per week for men or more than 7 alcoholic drinks per week for women, or illicit drug use that would interfere with safe participation or interpretation of study results.\n* Anemia or other hematologic condition that would increase risk from study blood collection.\n* Abnormal ECG or clinically significant cardiovascular finding that would increase risk from study procedures.\n* Impaired renal function or other clinically significant condition that would increase risk from study participation.\n* Known Wilson's disease, alpha-1 antitrypsin deficiency, hemochromatosis, or other non-MASLD chronic liver disease that would confound interpretation of study outcomes.\n* Any medical, surgical, or safety condition that, in the judgment of the PI, clinical co-investigator, CRC staff, anesthesia team, or bariatric surgeon, would make participation unsafe or interfere with completion of study procedures.","21 Years","70 Years",{"count":168,"type":21},20,[70],"This prospective, single-center pilot study will evaluate metabolic flux dysregulation in adults with obesity and suspected or confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) who are scheduled for protocol-eligible bariatric surgery at Vanderbilt University Medical Center. Participants will undergo research assessments before surgery, during the planned bariatric surgery encounter, and approximately 6 months after surgery. The study uses non-radioactive stable isotope tracer infusions, serial blood sampling, abdominal MRI\u002FMRE, and research tissue specimens collected only during clinically planned bariatric surgery to quantify hepatic and extrahepatic metabolic fluxes. The primary objective is to determine how hepatic citric acid cycle flux and related metabolic pathways change after bariatric surgery and how these metabolic measures relate to liver fat, liver stiffness, and biopsy-graded MASLD\u002FMASH severity.",[27,172,173,174],"Metabolic Dysfunction-Associated Steatohepatitis","Obesity","Bariatric Surgery",[143,176,177,178,179,180,181,182,183,184,185,186],"MASH","metabolic flux analysis","stable isotope tracer","bariatric surgery","Roux-en-Y gastric bypass","sleeve gastrectomy","liver fat","magnetic resonance elastography","citric acid cycle","gluconeogenesis","free fatty acid turnover","2026-08-07",{"date":189,"type":47},"2026-08-12",{"date":83,"type":21},{"date":192,"type":21},"2060-01-01",{"name":194,"class":88},"Vanderbilt University Medical Center",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":205,"conditions":206,"keywords":211,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},"100650607","liver-steatosis-and-fibrosis-in-non-celiac-wheat-sensitivity-patients-a-prospective-study-100650607","NCT07750535","Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","Prevalence and Risk Factors of Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","The inclusion\u002Fexclusion criteria used to select the study population have been previously validated in other retrospective studies. Additional exclusion criteria related to steatosis and other liver diseases and specifically required for this study were adopted.\n\nInclusion criteria for Non-Celiac Wheat Sensitivity (NCWS) patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects with wheat-dependent symptoms, both gastrointestinal and extra-intestinal;\n* negativity of IgA and IgG anti-deamidated gliadin peptide (DPG) antibodies, immunoglobulin (Ig)A and IgG anti-tissue transglutaminase (tTG) antibodies, and anti-endomysial antibodies (EMA);\n* absence of duodenal villous atrophy, documented in all patients carrying the human leukocyte antigen (HLA) DQ2 and\u002For DQ8 haplotypes (therefore regardless of the negativity of celiac disease (CeD)-specific serum antibodies), evaluated when the patients had consumed a minimum of 100g of pasta and\u002For bread a day, for at least 45 days;\n* absence of IgE-mediated wheat allergy (WA): negative skin prick-test and\u002For specific serum IgE assay for wheat, gluten and gliadin);\n* resolution of symptoms on a strict standard elimination diet (i.e. extended oligoantigenic, excluding wheat, cow's milk, egg, tomato and chocolate and other foods self-reported by the patient as causing symptoms), followed for at least 4 weeks, and the recurrence of the same symptoms after double-blind placebo-controlled challenge (DBPCC) with wheat (for further details see below);\n* complete medical records;\n* duration of follow-up longer than 12 months after initial diagnosis, with at least 2 outpatient visits during the follow-up period.\n\nInclusion criteria for Irritable Bowel Syndrome\u002FFunctional Dyspepsia (IBS\u002FFD) and other functional gastrointestinal disorders unrelated to NCWS or other food allergies\u002Fintolerances patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects diagnosed with IBS\u002FFD and other functional gastrointestinal disorders, according to the Rome IV classification, 1 who did not specifically report symptoms\u002Fsigns, whether gastrointestinal or extra-intestinal, following ingestion of wheat or other foods and who did not respond to gluten-free diet (GFD).\n\nInclusion criteria for Celiac Disease (CeD) patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects with gastrointestinal and extra-intestinal wheat-dependent symptoms that meet the diagnostic criteria of CeD 2: positivity of anti-tTG IgA and\u002For IgG antibodies and evidence of villous atrophy, according to the Marsh-Oberhuber classification, demonstrated by histology on duodenal biopsy;\n* clinical response to the GFD: resolution of gastrointestinal and\u002For extra-intestinal symptoms.\n\nExclusion criteria for all the patients enrolled in the study\n\n* self-exclusion of wheat from the diet and refusal to reintroduce it for diagnostic purposes, before entering the study;\n* drug abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system (e.g., wheat allergy, microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.), neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity;\n* incomplete medical records;\n* lack of clinical follow-up for at least 12 months after diagnosis with \\>2 outpatient visits during the follow-up period.\n\nAdditional exclusion criteria related to liver steatosis and other liver diseases\n\n* absence of abdominal ultrasound (US) imaging performed before diagnosis (i.e. before starting the wheat-free\u002Fgluten-free diet in NCWS and CeD patients, and before any lifestyle modifications and\u002For drug\u002Fprebiotic\u002Fprobiotic intake in IBS\u002FFD patients);\n* incomplete clinical records, lacking the data considered for the present study;\n* chronic alcohol intake (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women);\n* chronic hepatotropic virus infections \\[hepatitis B virus (HBV) and hepatitis C virus (HCV)\\];\n* autoimmune liver diseases;\n* congenital metabolic liver diseases (e.g. alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, porphyria, other storage diseases, etc.);\n* chronic long-term treatment with drugs associated with both macrovesicular (glucocorticoids, estrogens, tamoxifen, amiodarone, methotrexate, and 5-fluorouracil) and microvesicular (glucocorticoids, valproic acid, tetracycline, and zidovudine) steatosis.","65 Years",{"count":204,"type":21},250,"Hypothesizing an intestinal barrier impairment as a common pathophysiological substrate of both Non Celiac Wheat Sensitivity (NCWS) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MAFLD), in a retrospective cohort study (data not yet published), demographic, clinical, laboratory and histology data of NCWS patients at the time of diagnosis, were analyzed and compared to control subjects with Irritable Bowel Syndrome\u002FFunctional Dyspepsia (IBS\u002FFD) and freshly diagnosed Celiac Disease (CeD). NCWS diagnosis was performed by a double-blind placebo-controlled wheat challenge. Steatosis was confirmed by ultrasound examination. Our retrospective data showed that the frequency of liver of steatosis was lower in NCWS than in IBS patients. In addition, it seems that pre-diagnosis avoidance of wheat in NCWS correlates with protection from steatosis. A subset of NCWS patients, recently exposed to wheat, with clinical features suggesting increased IP, seems to be predisposed to liver steatosis and fibrosis.\n\nTo validate the results of the retrospective study, the researchers planned the present prospective study, to analyze the prevalence of liver steatosis and fibrosis, evaluated by ultrasound (US) examination, FibroScan analysis \\[CAP (Controlled Attenuation Parameter) and LSM (Liver Stiffness Measurement) values\\], FIB-4 (Fibrosis-4) index, and NFS \\[Non-alcoholic fatty liver disease (NAFLD) Fibrosis Score\\], in patients with NCWS at the time of diagnosis, comparing them with two control populations of newly diagnosed IBS\u002FFD and CeD patients.",[27,207,208,209,210],"Non Celiac Wheat Sensitivity","Irritable Bowel Syndrome","Functional Dyspepsia","Celiac Disease",[212,213],"non-celiac wheat sensitivity","metabolic dysfunction-associated steatotic liver disease","2026-08-06",{"date":216,"type":47},"2026-08-11",{"date":218,"type":47},"2024-01-01",{"date":220,"type":21},"2030-12-31",{"name":222,"class":88},"University of Palermo",2,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":143,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":244,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":89},"100649789","the-effects-of-5-methyltetrahydrofolate-supplementation-in-patients-with-metabolic-dysfunction-associated-steatotic-liver-disease-100649789","NCT07740109","The Effects of 5-methyltetrahydrofolate Supplementation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease","The Effect of 5-methyltetrahydrofolate Supplementation on Serum Folate and Homocysteine Level and PPARα and TNFα Gene Expression in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: a Double-blind, Parallel Randomized Controlled Trial Study","Inclusion Criteria:\n\n* Adult men or women (18-50 years)\n* Diagnosis of MASLD (grade 1 or 2 of steatosis confirmed by ultrasound)\n* Body mass index (BMI) = 25-34.9 kg\u002Fm²\n* Providing written informed consent\n\nExclusion Criteria:\n\n* Pregnancy, lactation, or plans to get pregnant during the next three months.\n* Liver disease (viral hepatitis, autoimmune liver disease, cirrhosis, drug-induced hepatotoxicity, or alcoholic fatty liver disease), heart or renal failure, kidney stones, any neoplasia, inflammatory disease, hypothyroidism, hypercortisolism, or hypertension\n* Taking drugs affecting glucose or lipid metabolism, folate supplements, anti-obesity medications, weight-loss diets, or dietary supplements\n* Lifestyle factors known to impact folate status (current smoking, alcohol intake, recreational drug use)\n* Pre-existing conditions affecting folate status (malabsorptive or inflammatory bowel diseases, active celiac disease, gastric bypass surgery, atrophic gastritis, epilepsy, advanced liver disease, kidney dialysis, type 1 or 2 diabetes mellitus, or sickle cell trait\u002Fanemia)\n* Medications that interfere with B-vitamin metabolism (chloramphenicol, methotrexate, metformin, sulfasalazine, phenobarbital, phenytoin, primidone, triamterene, barbiturates)","50 Years",{"count":233,"type":21},44,[70],"To determine the effect of MTHF supplementation on serum folate and homocysteine level, metabolic, nutritional status, liver function, and PPARα and TNFα gene expression in patients with MASLD",[237,238,239,143,37,27,240,241,242,243],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Fatty Liver Disease (NAFLD)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","NAFLD (Nonalcoholic Fatty Liver Disease)","NAFLD (Non-alcoholic Fatty Liver Disease)","NAFLD - Non-Alcoholic Fatty Liver Disease","NAFLD - Nonalcoholic Fatty Liver Disease",[245,246,143,37,237,27],"5-methyltetrahydrofolate","homocysteine","2026-07-30",{"date":249,"type":47},"2026-07-31",{"date":251,"type":21},"2026-09-30",{"date":253,"type":21},"2027-08-30",{"name":255,"class":88},"Tabriz University of Medical Sciences",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":264,"sex":265,"minAge":266,"maxAge":18,"enrollmentInfo":267,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":268,"conditions":269,"keywords":274,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":89},"100649110","biomarker-panel-for-pcos-associated-liver-steatosis-in-adolescent-girls-compass-pedpcos-100649110","NCT07731373","Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)","COMPASS-PedPCOS: BMI-Independent Mechanistic Dissection of PCOS-Associated MASLD in Adolescent Girls With Obesity Using an Expanded Biomarker Panel - A Single-Center Pre-Pilot Clinical Study","COMPASSpedPCOS","Inclusion Criteria:\n\n* Female, aged 10 to 18 years, with written informed consent from a parent or legal guardian and written assent from the child.\n* Group 1 (PCOS with obesity): both hyperandrogenism and oligo-anovulation required, based on adolescent-adapted Rotterdam criteria; body mass index at or above the 95th percentile.\n* Group 2 (Obesity control): body mass index at or above the 95th percentile, without features of PCOS, matched to Group 1 for age and body mass index.\n* Group 3 (Healthy control): healthy normal-weight girls (body mass index between the 5th and 84th percentile) without chronic disease, hyperandrogenism, or menstrual irregularity.\n\nExclusion Criteria:\n\n* Known acute or chronic liver disease (including viral, autoimmune, or Wilson disease) or use of hepatotoxic medication.\n* Endocrine disorders or secondary hyperandrogenism, including Cushing syndrome, hypothyroidism, uncontrolled diabetes mellitus, congenital adrenal hyperplasia, androgen-secreting tumour, or hyperprolactinaemia.\n* Syndromic or monogenic obesity (including Prader-Willi syndrome, Bardet-Biedl syndrome, Alström syndrome, MC4R or LEP variants) or a known genetic disorder.\n* Use of relevant or hepatotoxic medication within the preceding three months, including corticosteroids, metformin, oral contraceptives, valproic acid, or antiandrogens.\n* Pregnancy or regular alcohol use.\n* Refusal of consent or assent.",true,"FEMALE","10 Years",{"count":100,"type":21},"This single-center, prospective, observational, cross-sectional mechanistic pilot study will evaluate whether polycystic ovary syndrome (PCOS) contributes to hepatic steatosis in adolescent girls independently of adiposity. A total of 150 girls aged 10-18 years will be enrolled into three groups of 50: girls with PCOS and obesity, age- and body mass index-matched girls with obesity but without PCOS, and healthy normal-weight girls. Each participant will undergo a single evaluation comprising anthropometry, clinical and biochemical phenotyping, transient elastography with controlled attenuation parameter and two-dimensional shear wave elastography, and a single venous blood sample.\n\nAn extended biomarker panel will be measured by enzyme-linked immunosorbent assay (Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30 and M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone, and 11beta-hydroxyandrostenedione), together with liquid chromatography-tandem mass spectrometry measurement of testosterone and sex hormone-binding globulin, and genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567. The primary objective is to compare hepatic steatosis and the hepatokine\u002Fadipokine profile between the PCOS with obesity group and the adiposity-matched obesity control group, adjusting for body mass index z-score, insulin resistance, and free androgen index. No therapeutic intervention is assigned by the study protocol.",[270,27,271,272,273],"Polycystic Ovary Syndrome (PCOS)","Pediatric Obesity","Hyperandrogenism","Insulin Resistance Syndrome",[275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290],"HSD17B13","PNPLA3","11-oxygenated androgens","GDF-15","sCD163","CK-18","visfatin","adiponectin","FGF-21","Fetuin-A","PCOS","adipokine","hepatokine","transient elastography","controlled attenuation parameter","hepatic steatosis","2026-07-29",{"date":247,"type":47},{"date":294,"type":21},"2026-09-01",{"date":296,"type":21},"2027-09-01",{"name":298,"class":299},"Kayseri City Hospital","OTHER_GOV",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":308,"maxAge":18,"enrollmentInfo":309,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":89},"100649102","non-invasive-diagnostic-panel-for-masld-in-children-with-obesity-100649102","NCT07731360","Non-Invasive Diagnostic Panel for MASLD in Children With Obesity","A Non-Invasive Diagnostic Panel for MASLD in Children With Obesity: Evaluation of a Multiparametric Biomarker Panel and Genetic Risk Score Using LASSO-Regularized Logistic Regression - The PedMASLD-MultiOmics Pilot Study","PedMASLD-Pilot","Inclusion Criteria:\n\n* Age 8 to 18 years.\n* Body mass index at or above the 85th percentile for age and sex according to Turkish national growth references.\n* Hepatic steatosis of grade 1 or higher on abdominal ultrasonography and\u002For alanine aminotransferase at or above the biology-based upper limit of normal (26 U\u002FL for boys; 22 U\u002FL for girls), or persistent alanine aminotransferase elevation at or above twice the upper limit of normal (50 U\u002FL for boys; 44 U\u002FL for girls).\n* At least one cardiometabolic risk factor.\n* Written informed consent provided by a parent or legal guardian, with simplified assent for children aged 8 to 11 years and standard assent for children aged 12 years and older.\n\nExclusion Criteria:\n\n* Viral hepatitis.\n* Autoimmune liver disease.\n* Wilson disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.\n* Use of hepatotoxic medication, including corticosteroids, methotrexate, valproate, amiodarone, or tamoxifen.\n* Fasting duration shorter than 12 hours.\n* Active infection, defined as C-reactive protein above 10 mg\u002FL.\n* Untreated thyroid disorder, defined as thyroid-stimulating hormone below 0.5 or above 5.\n* Total parenteral nutrition.\n* Diabetic ketoacidosis.\n* Inability to obtain informed consent.","8 Years",{"count":310,"type":21},180,"This prospective, single-center, two-group observational study evaluates a non-invasive multi-parameter diagnostic panel for metabolic dysfunction-associated steatotic liver disease (MASLD) in children with obesity. A total of 180 children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex are planned for enrollment at a single tertiary pediatric center.\n\nEach participant attends a single study visit comprising a fasting venous blood sample for serum biomarkers (cytokeratin-18 M30 and M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7, adiponectin, leptin, insulin, and routine biochemistry), abdominal ultrasonography with two-dimensional shear wave elastography, and genotyping of three MASLD-associated variants (PNPLA3 rs738409, TM6SF2 rs58542926, HSD17B13 rs72613567).\n\nParticipants are classified as MASLD-positive or MASLD-negative according to a guideline-based composite reference standard consisting of ultrasonographic steatosis grading and cardiometabolic risk factor criteria, assessed independently of the candidate index tests. The primary objective is to determine the discriminative performance, expressed as the area under the receiver operating characteristic curve, of a LASSO-regularized logistic regression model combining biomarker, elastography, and genetic predictors. No therapeutic intervention is assigned by the study protocol. Reporting will follow the STARD 2015 statement.",[27,271,273],[143,37,271,314,315,316,317,318,319,276,320,321,322],"Non-Invasive Diagnosis","Cytokeratin-18","FGF21","RBP4","IGFBP7","Shear Wave Elastography","Polygenic Risk Score","LASSO","Diagnostic Accuracy",{"date":247,"type":47},{"date":325,"type":21},"2026-07-01",{"date":327,"type":21},"2027-06-01",{"name":298,"class":299},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":264,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100600119","the-impact-of-pectin-supplementation-on-systematic-inflammation-pathway-gut-microbiome-and-metabolic-health-in-patients-with-metabolic-dysfunction-associated-steatotic-liver-disease-masld-100600119","NCT07093346","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomised, Placebo-Controlled, Dietary Intervention Study","PEC-MASLD","Inclusion Criteria:\n\nInclusion criteria for the main study:\n\n* Patients with clinical diagnosis of MASLD (formerly termed non-alcoholic fatty liver disease (NAFLD)), having assessment suggesting that liver fat \\> 5% (e.g. histological evidence or\u002F and Transient Elastography using Controlled Attenuation Parameter (CAP)- FibroScan™ in the past month and\u002For liver imaging (such as ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI)).\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years who have a body mass index (BMI) between 18.5 and 39.9 kg\u002Fm2 and stable weight (weight gain or loss ≤ 3kg) for the past 3 months.\n* For diabetic participants: controlled blood glucose levels Haemoglobin A1C (HbA1c) \\\u003C7.0% (\\\u003C53 mmol\u002Fmol) \\[1\\].\n* Able to undergo CAP-FibroScan™.\n\nInclusion criteria for healthy participants who will have MRI scans:\n\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years.\n* participants with CAP\\\u003C250 kpa\\\u003C8kP by a FibroScan™ within the past 6 months.\n\nExclusion Criteria:\n\nExclusion criteria for the main study:\n\n* Have allergy toward soya, milk or chocolate.\n* Have allergy toward pectin.\n* Participants on vegan diet.\n* Have eating disorders or difficulties or gastrointestinal conditions e.g. malabsorptive conditions such as coeliac, Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) or gastroparesis.\n* Have chronic malnutrition condition.\n* History of major surgery which potentially limits participation or completion of the study.\n* History of previous intestinal surgery known to affect food intake or digestive function, including bariatric surgery.\n* Use of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.\n* Are taking the following medications: immunosuppressants, amiodarone and\u002For perhexiline.\n* Are currently following or anticipated to commence a specialised commercially available weight loss diet and\u002For program or concomitant use of any weight loss medication or herbal weight loss products.\n* History of side effects towards probiotics or prebiotics.\n* History or current psychiatric illness.\n* History or current neurological condition (e.g. epilepsy).\n* Participants with other liver abnormalities.\n* Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.\n* Have had a weight change exceeding 3 kg within 3 months.\n* Uncontrolled diabetes, active malignancy, or chronic infections.\n* Having symptoms of active infection.\n* Excessive alcohol intake defined as self-reported intakes greater than 21 units per week in men, and 14 units per week in women.\n* Participants who are pregnant, breast feeding or actively planning pregnancy will be excluded from the study.\n* Participation in any other trial in the last 3 months.\n\nExclusion criteria for healthy volunteers MRI scans and patients optional MRI scans:\n\n* Contraindications for MRI scanning: having pacemakers, defibrillators, neurostimulators, prohibited medical implants, and foreign bodies (e.g. bullets, shrapnel, metal slivers), history of metallic foreign body in eye(s) and penetrating eye injury that could present a risk during an MRI scan.\n* Difficulty breathing or inability to lie flat, as well as conditions that could worsen under stress (such as anxiety or panic disorders, claustrophobia, uncontrolled hypertension, or seizure disorders) severe enough to prevent undergoing an MRI.",{"count":338,"type":21},45,[70],"The goal of this clinical trial is to learn if daily supplementation with Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), can reduce systemic inflammation and improve gut microbiota composition in adults recently diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The main question it aims to answer is:\n\n-How does dietary Low-methoxy (LM) pectin supplementation affect systematic inflammation pathways such as those mediated by gut microbiota composition and what are the impacts on general metabolic indicators in individuals with MASLD?\n\nResearchers will compare a group taking 15g of LM-pectin with 10g of cocoa powder to a placebo group receiving 10g of placebo with 10g of cocoa powder to see if LM-pectin has measurable effects on inflammation and gut microbiota.\n\nParticipants will:\n\n* Take a daily supplement for 6 weeks: either 15g of LM-pectin with 10g of cocoa powder (intervention), or 10g of placebo with 10g of cocoa powder (control)\n* Provide stool and fasting blood samples before and after the intervention\n* Undergo anthropometric measurements (weight, height, waist\u002Fhip ratio, and blood pressure)\n* Complete a case report form (CRF) including demographics and health\u002Fmedical history\n* Undergo a FibroScan™ to assess liver health\n* (Optional) Participate in MRI scans to evaluate gut permeability",[237,238,239,143,37,27,240,241,242,243],[343,344,143,37,237,345,346,347,348,349,27],"LM pectin","pectin","Systemic Inflammatory Response","Dietary Fiber","Dietary Fibre","Diet","gut microbiota","2026-07-28",{"date":291,"type":47},{"date":353,"type":47},"2025-06-10",{"date":355,"type":21},"2027-03-31",{"name":357,"class":88},"University of Nottingham",3,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":366,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":377,"locationsCount":4},"100647996","association-between-metabolic-associated-fatty-liver-disease-and-obstructive-sleep-apnea-100647996","NCT07716995","Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea","OSA\u002FMAFLD","Inclusion Criteria:\n\n* Patients aged \\>18 years old\n* presented with a clinical suspicion of sleep-disordered breathing, including snoring, sleepiness and witnessed sleep apnea\n\nExclusion Criteria:\n\n* Patients aged ≤18 years old\n* Pregnancy\n* Presence of malignancy\n* Type I DM\n* Patients with fatty liver who undergone bariatric surgeries.\n* Patients with Central sleep apnea, upper airway resistance and narcolepsy\n* Patients with lung diseases with hypoxia\n* Previous history of alcohol consumption, steroids, proton pump inhibitors, antibiotics, and contraceptive pills",{"count":367,"type":21},127,"Association between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea",[370,27],"Obstructive Sleep Apnea","2026-07-21",{"date":373,"type":47},"2026-07-22",{"date":375,"type":21},"2026-08-01",{"date":296,"type":21},{"name":378,"class":88},"Assiut University",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":388,"studyType":101,"phases":4,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":89},"100647258","cardiovascular-risk-in-t2dm-with-mafld-a-cohort-study-100647258","NCT07706010","Cardiovascular Risk in T2DM With MAFLD: A Cohort Study","A Cohort Study on Cardiovascular Risk in Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-Associated Fatty Liver Disease","Inclusion Criteria:\n\n* 1.Age ≥18 years, male or female;\n\n  2.Meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) according to the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes (2022 edition), with a confirmed diagnosis for at least 3 months;\n\n  3.Meet the diagnostic criteria for metabolic dysfunction-associated steatotic liver disease (MASLD) according to the \\*Chinese Guideline for the Diagnosis and Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (2024 edition)\\*, with preliminary assessment including liver enzymes (ALT\u002FAST), liver ultrasound, and non-invasive fibrosis markers (FIB-4, LSM), and exclusion of other liver diseases;\n\n  4.Willing to participate in this study and provide written informed consent;\n\n  5.Able to cooperate with baseline survey and long-term follow-up (i.e., expected to reside in the study area during the follow-up period, without severe cognitive impairment, movement disorders, or other conditions that would interfere with follow-up).\n\nExclusion Criteria:\n\n* 1.Concomitant other chronic liver diseases: viral hepatitis (hepatitis B, hepatitis C, etc.), alcoholic liver disease (alcohol intake ≥140 g\u002Fweek for males, ≥70 g\u002Fweek for females), autoimmune liver disease, drug-induced liver injury, liver cirrhosis, liver cancer, etc.;\n\n  2.Concomitant severe cardiovascular or cerebrovascular disease, end-stage renal disease (CKD stage 5), malignant tumor, severe infection, etc., with an estimated life expectancy \\\u003C5 years;\n\n  3.Current use of medications that may significantly affect liver metabolism or glucose metabolism (other than routine glucose-lowering, lipid-regulating, or hepatoprotective agents) that cannot be adjusted;\n\n  4.Pregnant or lactating women, or those planning to become pregnant in the near term;\n\n  5.Severe mental illness or cognitive impairment that prevents cooperation with surveys and follow-up;\n\n  6.Refusal to sign informed consent, or inability to comply with study procedures.",{"count":387,"type":21},7000,"5 Years","This study aims to address the following key scientific question by establishing a large-scale, high-standard clinical cohort: the independent contribution of MASLD and its progression to liver fibrosis on cardiovascular outcomes in patients with T2DM, after excluding the confounding effects of traditional cardiovascular risk factors. Its technical value lies in utilizing prospective follow-up data combined with a multivariable competing risks model to develop and validate a cardiovascular risk prediction and early warning system tailored for Chinese populations with T2DM complicated by MASLD. Clinically, the findings will provide interdisciplinary evidence-based support for endocrinology and cardiology, helping clinicians identify high-risk individuals and prevent cardiovascular events through early intervention targeting hepatic metabolic disorders. This has significant implications for reducing overall mortality among diabetic patients in China and alleviating the public health burden.",[391,27],"Type 2 Diabetes (T2DM)","2026-07-10",{"date":394,"type":47},"2026-07-15",{"date":396,"type":21},"2026-07-12",{"date":398,"type":21},"2031-05-29",{"name":400,"class":88},"The Affiliated Hospital of Hangzhou Normal University",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":264,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":223},"100555009","targeting-the-skeletal-muscle-to-treat-metabolic-dysfunction-associated-steatotic-liver-disease-100555009","NCT06506513","Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease","Targeting Myosteatosis Though Physical Exercise to Treat Metabolic Dysfunction-associated Steatotic Liver Disease","MYO-MASLD","Inclusion Criteria:\n\n* confirmed MASLD at abdominal imaging\n* confirmed excessive muscle lipid content at imaging\n* stable weight\n\nExclusion Criteria:\n\n* severe comorbidities including active malignancies, neuromuscular degenerative diseases\n* contraindications to physical activity\n* excessive alcohol consumption",{"count":410,"type":21},60,[70],"Muscle changes including myosteatosis are reported as highly prevalent in metabolic dysfunction-associated steatotic liver disease (MASLD). Recent studies highlighted a link between muscle fat content and liver disease severity. Conversely, MASLD histological remission though diet or metabolic surgeries is also linked to a decrease in muscle fat content. Therefore, skeletal muscle appears as a potential target to treat MASLD.",[414],"Metabolic Dysfunction-associated Steatotic Liver Disease",[213,143,416,417,418,419,420],"physical activity","myosteatosis","magnetic resonance imaging","magnetic resonance specroscopy","muscle biopsy",{"date":422,"type":47},"2026-07-14",{"date":424,"type":47},"2025-09-01",{"date":426,"type":21},"2027-09",{"name":428,"class":88},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":202,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":117},"100580385","phase-1-a-study-to-evaluate-aln-cideb-in-adult-participants-with-metabolic-dysfunction-associated-steatotic-liver-disease-or-with-metabolic-dysfunction-associated-steatohepatitis-masldmash-100580385","NCT06836609","A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD\u002FMASH)","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Two Doses of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Key Inclusion Criteria:\n\n1. Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Part B: 18 to 65 years at Screening Visit 1 with a diagnosis of MASH, at Screening Visit 1\n2. Body Mass Index (BMI) ≥30 kg\u002Fm2 and ≤40 kg\u002Fm2 at Screening Visit 1\n3. Controlled-Attenuation Parameter (CAP) ≥285 dB\u002Fm by FibroScan during screening as described in the protocol\n4. Liver fat content ≥8.5% by MRI-PDFF during screening\n5. If on anti-hypertensive and\u002For lipid lowering medications and\u002For glucose lowering medications, must be on generally stable dose(s) for at least 12 weeks prior to screening and no changes to the dose(s) are anticipated during the study\n6. Part B: A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers (eg, evidence of fatty liver on imaging and elevated liver enzymes) and clinical risk factors, including having a history of 2 or more elements of metabolic syndrome, as defined in the protocol\n7. Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and\u002For liver biopsy\n2. Known historical or current diagnosis of other forms of chronic liver disease, as defined in the protocol\n3. Prior or current suspected or known drug-induced liver injury within 1 year prior to screening\n4. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score \\>12\n5. Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI\n6. Liver stiffness measurement, laboratory parameter assessment, estimated Glomerular Filtration Rate (GFR), and evidence of uncontrolled hypertension, as defined in the protocol\n7. Evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B Virus (HBV) infection, or Hepatitis C Virus (HCV) infection during screening, as described in the protocol\n8. History of Type 1 Diabetes\n9. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, within approximately 5 years prior to randomization or planned during the study period\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":437,"type":21},132,[439,440],"PHASE1","PHASE2","This study is researching an experimental drug called ALN-CIDEB, also referred to as \"study drug\". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver.\n\nThe aim of the study is to see how safe and tolerable the study drug is.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How the study drug works to change liver fat content\n* How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times",[27,172],[444,143,176],"Obese","2026-07-07",{"date":112,"type":47},{"date":448,"type":47},"2025-04-28",{"date":450,"type":21},"2027-05-15",{"name":452,"class":54},"Regeneron Pharmaceuticals",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":461,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":469,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":89},"100646296","taiwan-green-propolis-for-blood-lipids-and-body-fat-in-patients-with-masld-100646296","NCT07692438","Taiwan Green Propolis for Blood Lipids and Body Fat in Patients With MASLD","A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Effectiveness of Taiwan Green Propolis Supplementation on Blood Lipids and Body Fat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","TGP-MASLD","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Diagnosis of hepatic steatosis (fatty liver) confirmed by abdominal ultrasound, PLUS at least one of the following metabolic risk factors:\n\n  1. Overweight or obesity: BMI \\>= 23 kg\u002Fm\\^2\n  2. Elevated waist circumference: \\>= 90 cm in men or \\>= 80 cm in women (South Asian and Chinese criteria)\n  3. Dysglycemia or type 2 diabetes: prediabetes (HbA1c 5.7-6.4%, or fasting glucose 100-125 mg\u002FdL, or OGTT 2-hour glucose 140-199 mg\u002FdL) OR type 2 diabetes (HbA1c \\>= 6.5%, or fasting glucose \\>= 126 mg\u002FdL, or OGTT 2-hour glucose \\>= 200 mg\u002FdL, or current pharmacological treatment for type 2 diabetes)\n  4. Elevated triglycerides: \\>= 150 mg\u002FdL or currently on lipid-lowering therapy\n  5. Low HDL-C: \\\u003C= 39 mg\u002FdL in men or \\\u003C= 50 mg\u002FdL in women, or currently on lipid-lowering therapy\n  6. Elevated blood pressure: \\>= 130\u002F85 mmHg or currently on antihypertensive treatment\n\nExclusion Criteria:\n\n* Known allergy to honey, propolis, multiple pollens, or alcohol\n* Psychiatric disorder or cognitive impairment\n* Currently pregnant or breastfeeding\n* Significant endocrine abnormality, or major disease of the heart, liver (other than MASLD), or kidney\n* Difficulty swallowing capsules\n* Dementia, impaired consciousness, or inability to respond to questionnaires","80 Years",{"count":410,"type":21},[70],"Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common chronic liver condition linked to excess body fat, high blood lipids, and other metabolic problems. Taiwan green propolis is a natural health product collected by bees from plants, which has shown potential benefits for blood lipids and body fat in laboratory and animal studies. However, its effects in people with MASLD have not been well established in clinical trials.\n\nThis study is a double-blind, randomized, placebo-controlled trial enrolling up to 60 adults with MASLD at Dalin Tzu Chi Hospital in Taiwan. Eligible participants are randomly assigned in a 1:1 ratio to receive either Taiwan green propolis capsules or matching placebo capsules for 12 weeks. Participants take 2 capsules before breakfast and 2 capsules before dinner each day (4 capsules per day total). Neither participants nor the research team know which capsules are being taken until the study ends.\n\nThe study measures changes in blood lipids (triglycerides, total cholesterol, LDL-C, and HDL-C), body fat percentage, body weight, waist circumference, liver enzymes, blood sugar levels, inflammatory markers, and health-related quality of life. Liver fat and scarring are assessed by abdominal ultrasound before and after the intervention. Gut microbiota samples are also collected. Assessments are conducted at baseline, at 4 weeks, 8 weeks, 12 weeks (end of intervention), and at follow-up visits 2 weeks and 12 weeks after the intervention ends.\n\nThe goal of this study is to provide scientific evidence on whether Taiwan green propolis can safely and effectively improve blood lipids, body fat, and metabolic health in people with MASLD, and to explore the relationship between physiological improvements and health behavior changes.",[27,466,467,468],"Non-alcoholic Fatty Liver Disease NAFLD","Dyslipidemia","Obesity & Overweight",[470,471,472,143,473,474,475],"green propolis","propolis","dietary supplement","fatty liver","blood lipids","randomized controlled trial","2026-07-02",{"date":478,"type":47},"2026-07-09",{"date":480,"type":47},"2025-05-28",{"date":482,"type":21},"2028-09-30",{"name":484,"class":88},"Taipei Medical University",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":493,"briefSummary":494,"conditions":495,"keywords":510,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":223},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":437,"type":21},[70],"Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[173,496,497,498,27,172,143,176,499,500,501,502,503,504,505,506,507,508,509],"Liver Diseases","Liver Fibrosis","Liver Fat","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[511,512,513,514,515,516,517,518,31,519,520,521,522],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)","2026-06-23",{"date":525,"type":47},"2026-06-25",{"date":527,"type":47},"2025-06-24",{"date":529,"type":21},"2028-06",{"name":531,"class":88},"Pichamol Jirapinyo, MD, MPH",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":231,"maxAge":540,"enrollmentInfo":541,"targetDuration":543,"studyType":101,"phases":4,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":562,"locationsCount":89},"100641243","automated-passive-case-finding-for-advanced-liver-fibrosis-in-masld-the-liverseek-programme-100641243","NCT07658755","Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme","Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)","LiverSeek","Inclusion Criteria:\n\n1. Age between 50 and 75 years (inclusive)\n2. Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres\n3. Presence of at least one of the following metabolic risk factor combinations:\n\n   * ALT above the upper limit of normal AND HbA1c ≥6.5%\n   * ALT above the upper limit of normal AND BMI \\>30 kg\u002Fm²\n   * BMI \\>30 kg\u002Fm² AND HbA1c ≥6.5%\n\nExclusion Criteria:\n\n1. Age \\\u003C50 years or \\>75 years\n2. Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)\n3. Prior fibrosis assessment within the preceding 12 months.","75 Years",{"count":542,"type":21},3000,"24 Months","LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab\u002FBiwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain.\n\nWhen a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI \\>30; BMI \\>30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 \\>1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation.\n\nThe primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.",[27,497,466,78,173,546],"Obesity Type 2 Diabetes Mellitus",[143,35,37,548,549,550,551,552,553,554,555],"liver fibrosis","FIB-4","ELF","MASEF","screening","passive screening","advanced practice nurse","lifestyle intervention","2026-06-14",{"date":558,"type":47},"2026-06-22",{"date":560,"type":47},"2024-10-01",{"date":296,"type":21},{"name":563,"class":88},"Hospital General Universitario Gregorio Marañon",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":572,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":588,"locationsCount":4},"100638856","phase-2-effects-of-short-term-perioperative-daidzein-intervention-on-liver-histopathology-in-patients-with-masld-100638856","NCT07623044","Effects of Short-term Perioperative Daidzein Intervention on Liver Histopathology in Patients With MASLD","Short-Term Daidzein Intervention in MASLD","DAIMAS","Inclusion Criteria:\n\n* Adults aged 18 to 70 years.\n* Male or female participants.\n* Scheduled to undergo elective laparoscopic cholecystectomy or other benign biliary surgery for benign biliary disease.\n* Diagnosis of metabolic dysfunction-associated steatotic liver disease based on hepatic steatosis shown by liver biopsy or imaging, including controlled attenuation parameter, ultrasound, or magnetic resonance imaging, together with at least one cardiometabolic risk factor.\n* Expected preoperative window of at least 28 days before surgery.\n* Able and willing to provide written informed consent.\n* Willing to provide blood samples, urine samples, and intraoperative liver tissue samples.\n* Able and willing to avoid soy-containing foods during the study period, including soybeans, edamame, black soybeans, soy milk, tofu, dried tofu, tofu skin, yuba, tofu pudding, natto, miso, fermented soybeans, tempeh, and other traditional or fermented soy products.\n\nExclusion Criteria:\n\n* Viral hepatitis, autoimmune liver disease, drug-induced liver injury, Wilson disease, or other clearly defined chronic liver diseases.\n* Significant alcohol consumption, defined as more than 140 g per week for women or more than 210 g per week for men.\n* Liver cirrhosis, decompensated liver disease, or hepatobiliary malignancy.\n* Use of antibiotics, probiotics, soy isoflavone-containing products, or hormone-like dietary supplements within 4 weeks before enrollment.\n* Treatment within 3 months before enrollment that may substantially affect body weight or the severity of fatty liver disease.\n* Known allergy to soy products, daidzein, or isoflavones.\n* Pregnancy or breastfeeding.\n* Any condition that, in the opinion of the investigator, makes the participant unsuitable for this study.",{"count":233,"type":21},[440],"This clinical trial aims to learn whether daidzein can improve liver tissue changes in adults with metabolic dysfunction-associated steatotic liver disease, also called MASLD. MASLD is a liver condition linked to extra fat in the liver and metabolic problems such as obesity, diabetes, abnormal blood lipids, or high blood pressure.\n\nDaidzein is a natural compound found in soy. Earlier laboratory studies suggest that daidzein may help protect the liver. This study will test whether taking daidzein for a short time before surgery can improve liver tissue findings in people with MASLD.\n\nThe main questions this study aims to answer are:\n\nDoes short-term daidzein treatment improve liver tissue injury in people with MASLD? Is daidzein safe and well tolerated before surgery? Are changes in blood or urine equol levels related to the effects of daidzein? Equol is a substance made by gut bacteria after some people take daidzein.\n\nResearchers will compare people who take daidzein before surgery with people who receive standard care without daidzein.\n\nParticipants will:\n\nBe adults with MASLD who are scheduled for elective gallbladder surgery or another benign biliary surgery.\n\nBe randomly assigned to take daidzein or to receive standard care without daidzein.\n\nTake daidzein by mouth for 28 days before surgery if assigned to the daidzein group.\n\nAvoid soy foods during the study period. Provide blood and urine samples. Have a small liver tissue sample collected during surgery. Be followed for safety and recovery after surgery.\n\nThe liver tissue sample will be used to check liver fat, inflammation, and liver cell injury. Researchers will also study markers related to liver injury, immune activity, and how the body responds to daidzein.",[27],[577,578,579,580,581],"Metabolic dysfunction-associated steatotic liver disease","Daidzein","Ferroptosis","Randomized controlled trial","Soy isoflavone","2026-06-01",{"date":584,"type":47},"2026-06-03",{"date":586,"type":21},"2026-05-21",{"date":150,"type":21},{"name":589,"class":88},"Eastern Hepatobiliary Surgery Hospital",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":597,"maxAge":598,"enrollmentInfo":599,"targetDuration":4,"studyType":22,"phases":601,"briefSummary":602,"conditions":603,"keywords":605,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":89},"100628274","phase-2-smart-diets-for-masld-100628274","NCT07459504","SMART Diets for MASLD","A Sequential Multiple Assignment Randomized Trial of Diet Treatments for Hepatic Steatosis and Cardiometabolic Risk in Youth","Inclusion Criteria:\n\n* Children 11 to 17-years-old at the time of consenting\n* Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI\n* At least 1 of the following cardiometabolic risk factors: BMI greater than or equal to 85th percentile for age\u002Fsex or WC greater than 95th percentile, Abnormal cholesterol or triglyceride levels, Blood pressure BP greater than or equal to 95th percentile OR greater than or equal to 130\u002F80 and\u002For signs of insulin resistance (Acanthosis Nigricans OR HOMA-IR of greater 2.0 and greater 2.6 in prepubertal and pubertal children, respectively, Fasting Insulin Level of 10 pIU\u002FmL in prepubertal children and of 17 pIU\u002FmL and 13 pIU\u002FmL in pubertal girls and boys, respectively, OR Prediabetes)\n* ALT greater than or equal to 40 U\u002FL\n* Currently consumes greater than or equal to 2 eight-ounce sugar drinks (or juice) per week.\n* Patients of childbearing potential agrees to use adequate one or more effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n* Patients who are taking medications that can affect insulin (e.g., metformin, corticosteroids), most be on a stable dosage for at least 3 months prior to enrollment of the trial.\n* Written informed consent from parent or legal guardian, assent from child.\n\nExclusion Criteria:\n\n* Patients with Diagnosed Type 2 or Type 1 Diabetes Mellitus (T2DM) or HbA1c of \\>6.5 mg\u002FdL at baseline\n* Patients diagnosed with or suspected to have a chronic liver disease other than MASLD by screening labs or evaluation (i.e autoimmune, viral). Screening labs are defined as: Hepatitis B surface antigen, Hepatitis C virus total antibody, IgG, ceruloplasmin, and alpha 1 antitrypsin phenotype.\n* Patients unable to complete MRI or Labs required for the study.\n* Current participation in another clinical trial\n* Current participation in a weight loss program or obesity treatment program or clinic\n* Cancer or history of cancer within 5 years\n* Severe illness that required hospitalization in the last 60 days\n* Use of medications known to cause liver steatosis (TPN, amiodarone, chronic oral steroids, etc.)\n* Patients with implanted metal devices that are not compatible with magnetic resonance imaging (MRI).\n* Intellectual disability or major psychiatric disorder limiting informed assent\n* Clinical evidence of cirrhosis or advanced liver disease by any one of the following abnormal labs: (Hemoglobin less than 10 g\u002FdL, White blood cell less than 3,500 cells\u002Fmm, Neutrophil count less than 1,500 cells\u002Fmm3 of blood, Platelets less than 130,000 cells\u002Fmm3 of blood, Direct bilirubin greater than 1.0 mg\u002FdL)\n* Elevated total bilirubin except if known to have Gilbert's syndrome and direct bilirubin in normal range.\n* Albumin less than 3.2 g\u002FdL\n* A history of international normalized ratio (INR) greater than 1.4\n* AST or ALT greater than 250 IU\u002FdL.\n* Compensated or decompensated cirrhosis with evidence of portal hypertension.\n* Patients is pregnant or breastfeeding.\n* Patients who have been enrolled in a recent clinical trial and had the last dose of investigational product within 30 days or 5 half-lives of the study drug, whichever is longer.","11 Years","17 Years",{"count":600,"type":21},102,[440],"This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and\u002For Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.",[604],"Metabolic-dysfunction Associated Steatotic Liver Disease",[143,606,607,608,609],"Adolescents","Liver","Sugar","Amino acid supplement","2026-05-28",{"date":582,"type":47},{"date":613,"type":21},"2026-06",{"date":615,"type":21},"2030-12-26",{"name":617,"class":88},"Michigan State University",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":625,"targetDuration":4,"studyType":22,"phases":627,"briefSummary":628,"conditions":629,"keywords":631,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":117},"100637072","phase-1-safety-tolerability-pharmacokinetic-and-pharmacodynamic-characteristics-of-act500-in-participants-with-metabolic-dysfunction-associated-steatotic-liver-disease-complicated-with-chronic-hepatitis-b-100637072","NCT07589400","Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B","A Multicenter, Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease Complicated With Chronic Hepatitis B.","Inclusion Criteria:\n\n* The participant fully understands the purpose, nature, methods of the trial, and the potential adverse reactions, voluntarily agrees to participate in this study, and signs the informed consent form.\n* Male or female participants aged between 18 and 60 years (inclusive) at the time of signing the informed consent form.\n* Liver fat content ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.\n* Liver stiffness measurement (LSM) by FibroScan during the screening period meets 8 kPa ≤ LSM \\\u003C 12 kPa, or liver biopsy results within 6 months prior to screening show stage F2\u002FF3 liver fibrosis.\n* Hepatitis B surface antigen (HBsAg) positive for \\>6 months at screening, or other evidence of chronic hepatitis B (CHB), with HBV DNA \\\u003C 20 IU\u002FmL.\n* Serum alanine aminotransferase (ALT) \\\u003C 5×ULN at screening.\n* Received nucleos(t)ide analog (NAs) therapy for at least 1 year prior to screening and are currently on stable NA therapy (including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, and tenofovir amibufenamide). Stable NAs therapy is defined as receiving the same treatment regimen within 3 months prior to screening.\n* Have at least one of the following metabolic disease risk factors:\n\nBMI ≥24.0 kg\u002Fm\\^2, or waist circumference ≥90 cm (male) and ≥85 cm (female); Prediabetes: fasting blood glucose ≥6.1 mmol\u002FL, or glycated hemoglobin (HbA1c) ≥5.7%; History of type 2 diabetes mellitus; 1.70 mmol\u002FL ≤ fasting serum triglycerides \\\u003C 5.6 mmol\u002FL; Fasting serum high-density lipoprotein cholesterol ≤1.0 mmol\u002FL (male) and ≤1.3 mmol\u002FL (female), or receiving stable-dose lipid-lowering therapy; Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg; or receiving stable-dose antihypertensive therapy with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg.\n\n* Both male and female participants must agree to use adequate contraceptive methods, where:\n\nMale participants: agree to use reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last dose, and have no sperm donation plans; Female participants: women of non-childbearing potential; or women of childbearing potential who are not pregnant or breastfeeding, must have a negative serum pregnancy test result at screening and within 1 day prior to the first dose, agree to use reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last dose, and have no oocyte donation plans.\n\nExclusion Criteria:\n\n* Concurrent other liver diseases, including but not limited to hepatitis C, hepatitis D, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed liver cancer, etc.\n* Participants with a previous or current history of other malignant tumors, liver cirrhosis (including imaging-confirmed or suspected cirrhosis, and liver biopsy-confirmed cirrhosis), or evidence of decompensated liver disease (such as ascites, esophagogastric variceal bleeding, hepatic encephalopathy), or with a history of liver transplantation.\n* Participants with a history or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmia (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n* Participants with persistent and clinically significant medical history of respiratory, nervous, gastrointestinal, immune, hematological or psychiatric diseases, which, in the opinion of the investigator, may impose additional risks on the participant.\n* Participants with type 1 diabetes or poorly controlled type 2 diabetes (fasting blood glucose \\>9 mmol\u002FL within 3 months prior to screening or glycated hemoglobin \\>9.5% at screening), or diabetic patients using hypoglycemic drugs other than metformin and insulin.\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² (calculated by the CKD-EPI formula) at screening, or with a history of severe renal impairment.\n* Known hemoglobinopathy, hemolytic anemia, sickle cell anemia; or hemoglobin \\\u003C115 g\u002FL in female participants and \\\u003C130 g\u002FL in male participants at screening; or any other conditions judged by the investigator to interfere with hemoglobin detection.\n* Any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) \\>2 times the upper limit of normal (ULN), total bilirubin (TBIL) \\>1.5 times the ULN, international normalized ratio (INR) \\>1.3, albumin \\\u003C35 g\u002FL, platelet count \\\u003C125×10⁹\u002FL, and serum triglycerides \\>5.6 mmol\u002FL.\n* Participants with body weight gain or loss \\>5% within 3 months prior to screening, or those receiving diet control, bariatric surgery, or using approved anti-obesity medications for weight loss indications.\n* Participants with a history of major trauma or surgery within 3 months prior to screening, or those scheduled to undergo surgery during the study period.\n* Excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening. Excessive drinking is defined as weekly ethanol intake ≥210 g for males and ≥140 g for females; or with a history of drug abuse\u002Fdependence or drug inhalation\u002Finjection within 1 year prior to screening.\n* Use of drugs with potential therapeutic effects on MASLD\u002FMASH within 3 months prior to screening (e.g., GLP-1 receptor agonists, DPP4 inhibitors, SGLT2 inhibitors, FGF21 analogues, resmetirom, etc.), or drugs that may induce MASLD\u002FMASH (e.g., amiodarone, methotrexate, tetracyclines, tamoxifen, estrogen at doses exceeding hormone replacement therapy, anabolic steroids, valproic acid, and other known hepatotoxic drugs); use of drugs that may affect the efficacy of hepatitis B treatment within 6 months prior to screening (e.g., anti-HBV drugs other than NAs, interferons, systemic immunomodulators, hepatitis B vaccines, etc.), or any other medications deemed by the investigator to interfere with the study.\n* Participation in other clinical drug trials within 6 months prior to screening.\n* Any positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis C virus antibody (HCV RNA test is required if positive, with the value below the quantitative lower limit of the local study center), hepatitis D virus antibody, or treponema pallidum antibody during the screening period.\n* Participants with allergic reactions to excipients of ACT500 or drugs with similar chemical structures to ACT500, or other drug allergies deemed ineligible for study participation by the investigator.\n* Any other conditions that render the participant unsuitable for this study as determined by the investigator, or participants who are unable to complete the trial due to personal reasons after signing the informed consent form (ICF).",{"count":626,"type":21},24,[439],"This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated with chronic hepatitis B (CHB). The trial plans to enroll 24 participants with MASLD complicated with CHB across three dose cohorts initially, each consisting of 8 participants who will receive oral ACT500 tablets once daily.",[414,630],"Chronic Hepatitis b",[414,630,632,633],"ACT500","NM6606","2026-05-11",{"date":636,"type":47},"2026-05-15",{"date":638,"type":21},"2026-05-30",{"date":640,"type":21},"2027-06-30",{"name":642,"class":54},"Xiamen Amoytop Biotech Co., Ltd.",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":265,"minAge":649,"maxAge":540,"enrollmentInfo":650,"targetDuration":4,"studyType":22,"phases":652,"briefSummary":653,"conditions":654,"keywords":657,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":665,"leadSponsor":667,"locationsCount":89},"100622672","impact-of-circadian-exercise-on-metabolic-dysfunction-associated-steatotic-liver-disease-in-postmenopausal-women-100622672","NCT07386665","Impact of Circadian Exercise on Metabolic Dysfunction-Associated Steatotic Liver Disease in Postmenopausal Women","Inclusion Criteria:\n\n* Women aged 45-75 years, postmenopausal for at least two years (stage +1a)\n* Body Mass Index (BMI) \\> 25 and \\\u003C 40 kg\u002Fm²\n* Diagnosed hepatic steatosis (via ultrasound hyperechogenicity, FibroScan CAP score \\>280, or histological confirmation)\n* Sedentary lifestyle (no regular structured exercise)\n* Willingness to be randomized and adhere to study procedures, including all assessments and visits\n* Sufficient Spanish proficiency to understand and follow study instructions\n* Consent to store biological samples for future research\n* Participants should have a healthy circadian rhythm\n\nExclusion Criteria:\n\n* Contraindications for MRI (e.g., claustrophobia, pacemaker, metal implants)\n* History of major cardiovascular, endocrine, neurological, or kidney disease, or any clinical abnormalities (to be judged by the study physician)\n* First-degree family history of sudden cardiac death\n* Alcohol or substance abuse\n* Psychiatric, psychotic, eating, or sleep disorders (to be judged by the study physician)\n* Prior bariatric surgery, diagnosed HIV\u002FAIDS, or inflammatory\u002Fautoimmune diseases\n* Cancer or any medical condition where exercise is contraindicated (to be judged by the study physician)\n* Recent or unstable metabolic conditions (e.g., diabetes, recent medication changes, or use of drugs affecting metabolism)\n* Recent (\\\u003C3 months) use of antibiotics, statins, glucocorticoids, hormonal therapies, amiodarone, or myelosuppressive agents\n* Participation in weight-loss programs or special diets (e.g., ketogenic, high-carb)\n* Shift workers or caregivers with frequent nocturnal disruptions","45 Years",{"count":651,"type":21},63,[70],"Type of Study: Clinical Trial\n\nGoal: The goal of this clinical trial is to investigate how performing exercise at different times of day (morning vs. evening) affects liver fat, cardiometabolic health, and gut microbiota in postmenopausal women.\n\nParticipant Population\u002FHealth Conditions: The study will involve 63 sedentary postmenopausal women (aged 45-75) diagnosed with metabolic dysfunction-associated steatotic liver disease.\n\nMain Questions: The main questions this study aims to answer are:\n\n* Does morning exercise reduce hepatic fat more effectively than evening exercise?\n* How does time-of-day-specific exercise influence cardiometabolic markers?\n* Do changes in gut microbiota contribute to the metabolic effects of exercise timing?\n\nParticipants Will:\n\nBe randomized into one of three groups: morning exercise, evening exercise, or a usual-care control group.\n\nFollow the assigned regimen for 12 weeks. The exercise groups will perform supervised aerobic and resistance training three times per week.\n\nProvide blood, stool, and imaging data before and after the intervention to determine the effects of the intervention.\n\nComparison Group:\n\nResearchers will compare the effects of morning vs. evening exercise (and usual care) on hepatic fat reduction and cardiometabolic improvement, as well as changes in gut microbiota.",[27,655,656],"Cardiometabolic Diseases","Exercise",[656,658,659,660],"Metabolism","Health","Women","2026-05-04",{"date":663,"type":47},"2026-05-08",{"date":582,"type":21},{"date":666,"type":21},"2027-12",{"name":668,"class":88},"Universidad de Almeria",{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":678,"conditions":679,"keywords":681,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":89},"100630430","mpv-as-a-predictor-for-acs-in-patients-with-masld-100630430","NCT07487571","MPV as a Predictor for ACS in Patients With MASLD","Mean Platelet Volume as a Predictor for Acute Coronary Syndrome in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease","MPV\u002FACS MASLD","Inclusion Criteria:\n\n* Adult patients aged ≥18 years.\n* Confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) based on clinical, laboratory, and imaging criteria).\n* Patients diagnosed with acute coronary syndrome (unstable angina, NSTEMI, or STEMI) for Group I.\n* MASLD patients without clinical or electrocardiographic evidence of acute coronary syndrome for Group II.\n* Patients who provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with chronic liver diseases other than MASLD (e.g., viral hepatitis, autoimmune hepatitis, alcoholic liver disease).\n* Patients with known hematological disorders affecting platelet count or function.\n* Patients receiving antiplatelet or anticoagulant therapy prior to blood sampling.\n* Patients with active infection, inflammatory diseases, or malignancy.\n* Patients with chronic kidney disease or end-stage renal failure.\n* Pregnant or lactating females.",{"count":410,"type":21},"The aim of this study is to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) in Sohag University Hospital.",[27,680],"Acute Coronary Syndromes (ACS)",[682,683,684,685,686],"Mean platelet volume","Cardiovascular risk","Platelet activation","Metabolic syndrome","Liver staetosis","2026-04-30",{"date":689,"type":47},"2026-05-06",{"date":691,"type":21},"2026-05-05",{"date":693,"type":21},"2026-12-01",{"name":695,"class":88},"Sohag University",{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":701,"acronym":702,"eligibilityCriteria":703,"healthyVolunteers":264,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":704,"targetDuration":706,"studyType":101,"phases":4,"briefSummary":707,"conditions":708,"keywords":709,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":716,"lastUpdatePostDateStruct":717,"startDateStruct":719,"completionDateStruct":721,"leadSponsor":723,"locationsCount":89},"100633725","samsung-s-viscosity-vs-canon-dispersion-slope-in-steatotic-liver-disease-savid-sld-100633725","NCT07530419","Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)","Prospective Evaluation of Samsung Medison 2D Shear Wave Elastography Viscoelasticity Parameters in Patients With Steatotic Liver Disease Using Canon Dispersion Slope Imaging as Reference Standard: A Single-Center Non-Interventional Observational Study","SAVID-SLD","Inclusion Criteria:\n\n* \\[Cohort A - Healthy reference\\]\n\n  * Adults ≥18 years old\n  * Currently undergoing living-donor evaluation at SNUH\n  * Donor evaluation confirms (a) hepatic steatosis \\\u003C5% by imaging or biopsy, (b) normal AST\u002FALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.)\n  * Provided written informed consent \\[Cohort B + C - Steatotic liver disease\\]\n  * Adults ≥18 years old\n  * Sonographically suspected or confirmed hepatic steatosis on B-mode ultrasound, scheduled for clinical abdominal ultrasound\n  * Serum AST\u002FALT results available within 6 weeks of ultrasound, or scheduled\n  * Provided written informed consent\n\nExclusion Criteria:\n\n* • Significant alcohol intake within the past 2 years (\\>30-60 g\u002Fday for males, \\>20-50 g\u002Fday for females)\n\n  * Diagnosed or strongly suspected chronic liver disease (active HBV\u002FHCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.)\n  * Suspected hepatic failure or decompensated cirrhosis (albumin \\\u003C3.2 g\u002FdL, INR \\>1.3, direct bilirubin \\>1.3 mg\u002FdL)\n  * Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible\n  * History of liver malignancy or treatment for liver malignancy\n  * History of liver surgery\n  * Pregnancy or lactation\n  * Inadequate ultrasound image quality due to obesity, bowel gas, or patient inability to cooperate",{"count":705,"type":21},95,"1 Week","Steatotic liver disease (SLD) is one of the most common chronic liver diseases worldwide. Distinguishing simple steatosis from metabolic dysfunction-associated steatohepatitis (MASH) with significant fibrosis is clinically important, but liver biopsy - the current standard - is invasive. Recent ultrasound technology allows noninvasive measurement of tissue viscoelasticity, which has been linked to liver inflammation. Samsung Medison's HERA W12 system (S-Viscosity) and Canon Aplio i800 (Dispersion Slope Imaging) both provide vendor-specific viscoelasticity parameters derived from shear-wave dispersion analysis, but their relationship and agreement have not been compared in SLD patients.\n\nThis prospective single-center observational study will enroll approximately 95-100 participants in three cohorts: (A) 15-20 living-donor candidates as a healthy reference, (B+C) approximately 80 adults with sonographically suspected or confirmed SLD recruited consecutively. SLD participants will be classified post-hoc into low-MASH-risk (Cohort B) and at-risk MASH (Cohort C) subgroups using a multi-parametric stratification combining liver stiffness (LSM), DeepUSFF (deep-learning-based ultrasound fat fraction), and serum AST. All participants will undergo same-day ultrasound examination with both Samsung HERA W12 and Canon Aplio i800. The primary objective is to evaluate the correlation and agreement between Samsung S-Viscosity and Canon Dispersion Slope. Secondary objectives include deriving a normal reference range from the healthy cohort, comparing viscoelasticity parameters across cohorts, and exploring a Modified US-FAST score.",[27,31,497],[710,711,712,713,714,143,176,715],"Shear wave elastography","Viscoelasticity","Dispersion slope","Liver stiffness","Quantitative ultrasound","S-Viscosity","2026-04-08",{"date":718,"type":47},"2026-04-15",{"date":720,"type":21},"2026-04-10",{"date":722,"type":21},"2027-02-28",{"name":724,"class":88},"Seoul National University Hospital",{"id":726,"slug":727,"hasResults":12,"nctId":728,"briefTitle":729,"officialTitle":730,"acronym":4,"eligibilityCriteria":731,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":732,"targetDuration":4,"studyType":22,"phases":734,"briefSummary":735,"conditions":736,"keywords":737,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":738,"lastUpdatePostDateStruct":739,"startDateStruct":741,"completionDateStruct":743,"leadSponsor":745,"locationsCount":89},"100605197","advanced-fibrosis-detection-for-masld-in-primary-care-100605197","NCT07159386","Advanced Fibrosis Detection for MASLD in Primary Care","Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care","Patients\n\nInclusion Criteria:\n\n* Patients with a diagnosis code for MASLD\n* Type 2 diabetes mellitus will\n\nExclusion Criteria:\n\n* All patients with cirrhosis, complications of cirrhosis (e.g. portal hypertension, hepatic encephalopathy), hepatocellular carcinoma, or previous liver transplant will be excluded.\n* pregnant women.\n\nClinicians Clinicians will also be study participants, as we will be surveying them for feedback on the MASLD fibrosis risk assessment intervention. The MUSC primary care network at last count employed 122 clinicians across the 27 primary care practices.\n\nInclusion criteria:\n\n1\\. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study.\n\nExclusion criteria:\n\nNone",{"count":733,"type":21},225,[70],"This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomized design. This work will generate generalizable data to dramatically enhance MASLD management in primary care.",[414],[504,607,173],"2026-03-30",{"date":740,"type":47},"2026-03-31",{"date":742,"type":47},"2026-03-16",{"date":744,"type":21},"2030-09",{"name":746,"class":88},"Medical University of South Carolina",{"id":748,"slug":749,"hasResults":12,"nctId":750,"briefTitle":751,"officialTitle":752,"acronym":143,"eligibilityCriteria":753,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":754,"targetDuration":4,"studyType":22,"phases":756,"briefSummary":757,"conditions":758,"keywords":759,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":760,"lastUpdatePostDateStruct":761,"startDateStruct":763,"completionDateStruct":765,"leadSponsor":767,"locationsCount":89},"100630538","phase-1-developing-microbial-therapy-for-masld-from-mechanism-to-clinical-validation-100630538","NCT07488975","Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation","Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Investigations to Clinical Trials","Inclusion Criteria:\n\n* Fibroscan，CAP ≧ 260db\u002Fm\n\nExclusion Criteria:\n\nA. Pregnant women or women who are breastfeeding. B. Use of probiotics and prebiotic-related products (including yogurt, yogurt, Yakult, etc.) within 14 days before the screening visit.\n\nC. Patients who have used antibiotics (except skin lotions) or antifungal drugs within 30 days before the screening visit.\n\nD. Use of glucagon-like peptide-1 receptor agonists (GLP1-RAs) within six months prior to the screening visit.\n\nE. Use of drugs that may affect the evaluation index within 14 days before the screening visit, during the screening visit, or during the planned trial period, such as steroids, immunosuppressants, or anti-inflammatory drugs, or drugs containing ingredients for treating hepatitis or affecting fat metabolism, including HMG-CoA reductase inhibitors (statins), fibrates, silymarin, thiazolidinediones, metformin, cholestyramine, ezetimibe, orlistat, and sodium-glucose transporter type 2 inhibitors (SGLT2i). This restriction does not apply if the above-mentioned drugs have been used continuously for more than six months and the dosage is not changed during the trial.\n\nF. Those who have had severe gastrointestinal infection diarrhea symptoms within 14 days before the screening visit (more than three watery stools in 24 hours).\n\nG. Have the following medical history or laboratory abnormalities:",{"count":755,"type":21},40,[439],"Metabolic dysfunction-associated steatotic liver disease (MASLD), redefined in 2020, is an improved diagnostic standard evolved from non-alcoholic fatty liver disease (NAFLD), emphasizing the correlation between hepatic steatosis and metabolic dysfunction. Compared to NAFLD, which relies on exclusion-based diagnosis, MASLD criteria enhance population homogeneity in studies and accommodate patients with coexisting liver diseases, thereby improving the efficiency and relevance of drug development. MASLD affects approximately one-quarter of the global population. If left untreated, it may progress to liver fibrosis, cirrhosis, or hepatocellular carcinoma. Given its high clinical burden and the current lack of FDA-approved therapies, effective treatments for MASLD are urgently needed.\n\nPrevious studies suggest that diet and gut microbiota play crucial roles in the pathogenesis of MASLD. Dietary composition influences microbial balance and intestinal barrier function. In dysbiosis, gut-derived harmful substances such as pathogen-associated molecular patterns (PAMPs) and microbiota-derived metabolites (MDMs) may translocate via a leaky gut to the liver through the portal vein, contributing to hepatic injury. These processes, often described as the gut-liver axis, remain incompletely understood.\n\nAnimal studies have shown that dietary components regulating gut microbiota may help alleviate MASLD. While clinical evidence remains limited, incorporating microbiota-modulating and immune-regulating food ingredients holds potential. Next-generation probiotics have demonstrated benefits in improving hepatic lipid metabolism and modulating gut microbiota, potentially slowing MASLD progression through gut-liver axis modulation.\n\nOur previous research investigated a pasteurized Akkermansia muciniphila strain, NTUH\\_Amuc03 (pAKK\\_LWHK0003), which attenuated fatty liver progression in preclinical models. In mice subjected to a high-fat, high-fructose, high-cholesterol diet, pAKK\\_LWHK0003 administration resulted in reduced body weight, improved dyslipidemia, lowered NAFLD activity scores, and improved HOMA-IR. These findings support the potential of pAKK\\_LWHK0003 in slowing MASLD progression.\n\nThis study aims to evaluate further the clinical efficacy and safety of pAKK\\_LWHK0003 in individuals with MASLD.",[27],[143,176],"2026-03-18",{"date":762,"type":47},"2026-03-23",{"date":764,"type":47},"2025-01-22",{"date":766,"type":21},"2026-12-31",{"name":768,"class":54},"Leeuwenhoek Laboratories Co. Ltd."]