[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-type-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-type-2":673},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,53,83,108,136,163,189,218,241,264,285,314,339,364,392,418,443,463,493,518,542,565,598,621,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100652068","a-prospective-multicenter-study-evaluating-the-metabolic-effects-of-pulsendo-therapy-in-adults-with-type-2-diabetes-100652068",false,"NCT07768631","Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes","A Prospective, Multicenter, Randomized, Sham-Controlled Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes (pULSENDO Study)","pulsENDO","Inclusion Criteria:\n\n1. 22- 75 years of age, inclusive.\n2. T2D diagnosis for at least 6 months.\n3. HbA1c of 7.5-10.5%, inclusive, for participants on 1-3 GLMs or or if on 4 glucose-lowering medications must have HbA1c between 7.5% - 9.0%, inclusive.\n4. BMI 27-40 kg\u002Fm2, inclusive.\n5. On 1-4 non-insulin glucose lowering medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit\n6. If on lipid-lowering medications, the medication stable for at least 12 weeks .\n7. Individualized metabolic surgery (IMS) score ≤ 115.\n8. Weight stability (≤5% weight change) for at least 12 weeks\n9. Agree not to donate blood during participation in the study.\n10. Women of childbearing potential must not be pregnant and using an acceptable method of contraception throughout the study.\n11. Willing and able to comply with study visits and study requirements.\n12. Understand and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with type 1 diabetes.\n2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.\n3. Fasting serum C-peptide \\\u003C1 ng\u002FmL (333pmol\u002Fl).\n4. Current use of insulin, or previous use of any types of insulin for \\>1 month at any time (except for treatment of gestational diabetes) in last 2 years.\n5. Hypoglycemic unawareness.\n6. History of ≥1 severe hypoglycemia episode in past 6 months\n7. Discontinuation of a GLP-1 or a GLP-1\u002FGIP dual-agonist within 6 months of the screening visit following at least one month of treatment.\n8. Known autoimmune disease\n9. Previous GI surgery that has changed GI anatomy\n10. Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure\n11. History of gastroparesis.\n12. Acute gastrointestinal illness in the last 7 days.\n13. Known history of inflammatory disease (e.g. Crohn's disease, ulcerative colitis, inflammatory bowel disease), radiation enteritis or other chronic inflammatory disorders of the bowel.\n14. History of chronic or acute pancreatitis.\n15. Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \\>3.0 times the upper limit of normal (ULN)\n16. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure.\n17. Use of systemic glucocorticoids for more than 10 consecutive days within 12 weeks\n18. Use of medications known to affect GI motility (e.g. metoclopramide\u002F Reglan)\n19. Current use of weight loss medications or other weight loss medications including over-the-counter \\[OTC\\] medications or have discontinued weight loss medications within 6 months.\n20. Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months.\n21. Persistent anemia, defined as hemoglobin \\\u003C10 g\u002FdL.\n22. Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.\n23. History of blood donation or transfusion within 3 months.\n24. Unstable or paroxysmal cardiac arrhythmia.\n25. Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, unstable angina, cerebrovascular accident (stroke), hospitalization due to congestive heart failure, or history of other significant cardiovascular disease\n26. Heart failure\u002Fvalvular disease: NYHA Class III or IV heart failure, or clinically significant valvular heart disease associated with symptoms or increased procedural\u002Fanesthesia risk\n27. Estimated glomerular filtration rate (eGFR) ≤ 45 ml\u002Fmin\u002F1.73m2\n28. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.\n29. History of secondary hypothyroidism or inadequately controlled primary hypothyroidism\n30. Presence of any implanted electronic devices that cannot be turned off during the procedure\n31. Presence of duodenal or biliary stents.\n32. Not a candidate for upper GI endoscopy or general anesthesia.\n33. Active illicit substance abuse or alcoholism (\\>2 drinks\u002Fday regularly).\n34. Active malignancy within the last 5 years (excluding non-melanoma skin cancers).\n35. Women who are breastfeeding.\n36. Participating in another ongoing clinical trial of an investigational drug or device.\n37. Current or history within the past 12 months of binge eating disorder, bulimia nervosa, anorexia nervosa, or night eating syndrome.\n38. Clinically significant psychiatric illness, defined as any of the following: (a) psychiatric hospitalization within the past 24 months; (b) a history of suicide attempt, or active suicidal ideation within the past 24 months; or (c) a diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder that is not clinically stable on current management\n39. Critically ill or has a life expectancy \\\u003C5 years.\n40. Are investigator site personnel directly affiliated with this study and\u002For their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n\n    Additional exclusion criteria to be evaluated during the screening process:\n41. HbA1c \\\u003C 7.5% or \\> 10.5% at baseline visit.\n42. Uncontrolled hyperglycemia with a glucose level \\>270 mg\u002Fdl (\\>15 mmol\u002FL) after an overnight fast or \\>360 mg\u002Fdl (\\>20 mmol\u002Fl) in a randomly performed measurement that is confirmed by a second measurement (not on the same day) between screening and baseline visit.\n43. Active systemic infection, febrile illness, or antibiotic use within 4 weeks of the Baseline visit.\n44. Vaccination within 14 days of the Baseline visit.\n45. Any severe hypoglycemic event since the screening visit.\n46. Poorly controlled hypertension, as evidenced by a mean of 3 separate blood pressure measurements \\>180 mmHg (systolic) or \\>100 mmHg (diastolic)\n47. Women of child-bearing potential with a positive urine pregnancy test at baseline visit.\n48. LA Grade C or greater esophagitis on endoscopy.\n49. Abnormalities of the GI tract preventing endoscopic access to the duodenum.\n50. Anatomic abnormalities in the duodenum or proximal jejunum that would preclude the completion of the treatment procedure, including tortuous anatomy.\n51. Endoscopic observation of upper gastrointestinal abnormalities such as ulcers, polyps in the area to be treated, varices, strictures, congenital or intestinal telangiectasia.\n52. Any other anatomical or endoscopic abnormalities\u002Fcharacteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure.","ALL","22 Years","75 Years",{"count":22,"type":23},320,"ESTIMATED","INTERVENTIONAL",[26],"NA","This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.",[29,30,31,32,33,34],"Diabetes Type 2","Diabetes","Diabetes (DM)","Weight Change","Glycemic Control","Glycemic Control for Diabetes Mellitus",[36,37,38,39,40],"blinded","multicenter","randomized","doudenal regeneration","type 2 diabetes","NOT_YET_RECRUITING","2026-08-14",{"date":44,"type":45},"2026-08-18","ACTUAL",{"date":47,"type":23},"2027-01-01",{"date":49,"type":23},"2030-11-01",{"name":51,"class":52},"Endogenex, Inc.","INDUSTRY",{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":24,"phases":64,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100604445","connected-care-for-type-2-diabetes-self-management-100604445","NCT07149610","Connected Care for Type 2 Diabetes Self-Management","Connected Care for Type 2 Diabetes: a Study Protocol for a Structured Self-Management Intervention Through Technology and Healthcare Collaboration","RCT_SM","Inclusion Criteria:\n\n* patients with T2DM (as confirmed by the physician's diagnosis);\n* belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno);\n* age \\> = 18;\n* resident in the Marche region;\n* HbA1c \\> 7 on most recent laboratory report within the last 3 months;\n* no changes in diabetes medication in the previous 6 months;\n* no prescription for any hypoglycaemic agent within the previous 4 weeks or taking a consistent dose of one or more oral hypoglycaemic agents for more than 12 weeks;\n* owning smartphone\u002Fmobile phone with an internet connection;\n* capable to consent;\n* fulfilling and signing the informed consent;\n* with self-reported competencies of communicating verbally in local language (corresponding to a level of Italian language knowledge =\\>A2 of the CEFR levels).\n\nExclusion Criteria:\n\n* acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and\u002For neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe\u002Fmajor depression and other relevant psychiatric disorders;\n* estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n* plan to receive surgery that could limit physical activity during the study period;\n* pregnant or breastfeeding;\n* participation in another studies;\n* lack of written informed consent.","18 Years",{"count":63,"type":23},388,[26],"The primary objective of this Randomized Clinical Trial is to improve the self-management (SM) competencies of patients affected by Type 2 Diabetes Mellitus (T2DM) living in the Marche region (Italy) through the support of a mobile health (m-health) solution personalised by the diabetologist and integrated with the Electronic Patient Record (EPR), assessed through the change in glycated haemoglobin (HbA1c) levels (%) from baseline to the end of the intervention (primary outcome).\n\nResearchers will compare the use of the m-health solution (treated group) to usual T2DM care (control group) in determining change in HbA1c levels (%). The intervention will start at the Diabetic Centres (CADs) where patients are currently followed up and will then take place in each participant's home\n\nParticipants of the treated group will:\n\n* receive dedicated training on the use of the m-health solution\n* receive the personalization of the m-health solution\n* use the m-health solution to: 1) track and view the data related to their health status (e.g., glycaemic status, lifestyle habits, diet) and treatment plane; 2) receive alerts and motivational messages; communicate with the Health Care Professionals (HCPs) of the Diabetic Centre (CAD) in case of need; 3) access to the educational material and to the technical assistance, when needed.\n\nHCPs will be able to monitor the patients' data and clinical parameters and to communicate with the patients. After a baseline evaluation (T0), three follow-up evaluations will be conducted at 4, 8 and 12 months (T1-T2-T3 respectively) , during the usual physician' visits, as part of clinical routine.\n\nThe evaluation phases (T0, T1, T2, T3) will be conducted through data derived from: 1) self-administered and paper-based questionnaires, validated in the Italian language; 2) the clinical assessment of patients; 3) the m-health solution, as data automatically derived from the m-health solution; 4) a focus group carried out in a subsample of participants.\n\nData regarding different health-related areas (T2DM severity; medication adherence; lifestyle habits; self-efficacy related to management of the disease; quality of life), usability of the m-health solution, participants' experience with the intervention, utilization of the m-health solution by the patients, and the cost-effectiveness of the intervention, will be evaluated.\n\nPatients participating in the study will not be required to make any additional visits or undergo any laboratory analysis beyond those specified in their therapeutic plan.",[29],[68,69,70,71,72],"self-management","digital solution","Diabete type 2","Chronic diseases","glycated hemoglobin","RECRUITING",{"date":44,"type":45},{"date":76,"type":45},"2025-10-13",{"date":78,"type":23},"2026-12-31",{"name":80,"class":81},"Marche Region Regional Health Agency","OTHER",11,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":24,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100652241","perioperative-meditation-music-intervention-in-patients-with-type-2-diabetes-undergoing-elective-surgery-100652241","NCT07770204","Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery","Effects of a Meditation Music Intervention on Glycemic Control, Anxiety, and Sleep Quality in Patients With Type 2 Diabetes Mellitus Undergoing Elective Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes mellitus.\n* Scheduled to undergo elective surgery.\n* Aged 40 to 70 years.\n* Mentally and psychologically competent.\n* Able to communicate effectively.\n* Willing to participate and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Severe hearing impairment or use of a hearing aid.\n* Diagnosis of severe depression, anxiety disorder, or cognitive impairment (e.g., dementia or Alzheimer's disease).\n* Initiation of anxiolytic, sedative, or hypnotic medication within the previous month.\n* History of substance abuse or severe alcohol use disorder.\n* Diagnosis of type 1 diabetes mellitus or use of an insulin pump.","40 Years","70 Years",{"count":93,"type":23},84,[26],"Patients with type 2 diabetes mellitus undergoing elective surgery are at increased risk of perioperative hyperglycemia, anxiety, and poor sleep quality because of the physiological and psychological stress associated with surgery. These factors may negatively affect postoperative recovery and increase the risk of complications.\n\nMusic-based interventions are safe, inexpensive, and non-pharmacological approaches that may reduce anxiety, improve sleep quality, and help regulate physiological stress responses. However, evidence regarding the effects of perioperative meditation music on glycemic control, anxiety, and sleep quality in patients with type 2 diabetes undergoing elective surgery remains limited.\n\nThis randomized controlled trial aims to evaluate the effectiveness of perioperative meditation music in adults with type 2 diabetes mellitus undergoing elective surgery. Participants will be randomly assigned to either an intervention group receiving routine perioperative care plus meditation music or a control group receiving routine perioperative care alone. The intervention group will listen to self-selected meditation music at predefined perioperative time points before and after surgery.\n\nBrief Summary The primary objective is to determine whether perioperative meditation music improves postoperative glycemic control. Secondary objectives are to evaluate its effects on anxiety levels and sleep quality. Anxiety will be assessed using the State Anxiety Inventory (STAI-State), sleep quality will be measured using the Richards-Campbell Sleep Questionnaire, and glycemic control will be evaluated using routinely measured blood glucose values.\n\nThe findings of this study may provide evidence for the use of meditation music as a simple, safe, and cost-effective nursing intervention to improve perioperative outcomes in patients with type 2 diabetes mellitus undergoing elective surgery.",[29],[98],"Perioperative Care, Meditation Music, Elective Surgery, Anxiety, Sleep Quality, Glycemic Control, Nursing Intervention","2026-08-13",{"date":44,"type":45},{"date":102,"type":45},"2026-06-03",{"date":104,"type":23},"2027-06-30",{"name":106,"class":81},"İstanbul Aydın Üniversitesi",1,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":115,"minAge":61,"maxAge":20,"enrollmentInfo":116,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":107},"100652193","phase-4-the-effect-of-empagliflozin-and-metformin-on-oxidative-capacity-and-microvascular-reactivity-of-skeletal-muscle-in-patients-with-type-2-diabetes-mellitus-100652193","NCT07771010","The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus","EMPOWER","Inclusion Criteria:\n\n* Male sex\n* Age 18-75 years\n* Newly diagnosed type 2 diabetes mellitus, confirmed no more than 2 years prior to enrollment\n* Body mass index (BMI) 25-35 kg\u002Fm²\n* Currently managed at a diabetes outpatient clinic\n* No known chronic diabetes-related complications\n* No prior antidiabetic pharmacological treatment, with the exception of sulfonylureas\n\nExclusion Criteria:\n\n* Other forms of diabetes mellitus (i.e., not type 2)\n* Type 2 diabetes mellitus known for more than 2 years\n* Comorbidities known to independently affect skeletal muscle oxidative capacity, including: spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, cystic fibrosis, local joint immobility, or hemiplegia\n* Known mitochondrial disease\n* Heart failure, NYHA class II or higher\n* Chronic kidney disease, stage 3 or higher\n* Poorly controlled chronic medical conditions (e.g., arterial hypertension, hypothyroidism)\n* Recurrent urinary tract infections\n* Active malignancy currently undergoing oncologic treatment\n* Life expectancy less than 3 months\n* Symptomatic hyperglycemia with fasting plasma glucose above 18 mmol\u002FL, HbA1c ≥ 10%\n* Unwillingness to provide informed consent","MALE",{"count":117,"type":23},54,[119],"PHASE4","The purpose of the study is to compare the effect of empagliflozin, metformin, and the combination of both on the oxidative capacity of skeletal muscle and its microvascular reactivity in individuals with newly diagnosed type 2 diabetes. As the primary outcome, the investigators selected the change in skeletal muscle oxidative capacity and posed the following scientific question: Does empagliflozin significantly improve the oxidative capacity of skeletal muscle? The study will enroll 54 individuals with type 2 diabetes in a prospective, randomized, interventional, open-label study. Participants will be randomized into 3 equally sized groups: 1) a group receiving empagliflozin; 2) a group receiving metformin; and 3) a group receiving a combination of both drugs (empagliflozin and metformin). The investigators will analyze the clinical variables of the subjects, near-infrared spectroscopy (NIRS) measurements over the flexor digitorum superficialis muscle of the non-dominant arm at rest, after submaximal muscular work, and during transient brachial artery occlusion at specified time intervals (14 days, 1 month, 3 months, 6 months), as well as body composition, physical performance, and glycemic control following the pharmacological intervention.",[29],[123,124,125,126,127,128],"type 2 diabetes mellitus","Empagliflozin","Metformin","Skeletal muscle oxidative capacity","Near-infrared spectroscopy","Microvascular reactivity",{"date":44,"type":45},{"date":131,"type":45},"2026-04-16",{"date":133,"type":23},"2028-07-31",{"name":135,"class":81},"University Medical Centre Ljubljana",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":107},"100651439","metformin-effects-according-to-slc16a11-carrier-status-100651439","NCT07760883","Metformin Effects According to SLC16A11 Carrier Status","Effect of Metformin in Individuals With Type 2 Diabetes According to SLC16A11 Risk Variant Carrier Status","Met-SLC16A11","Inclusion Criteria:\n\n* Male and female participants\n* Aged 18 to 65 years\n* Diagnosis of type 2 diabetes\n* Estimated glomerular filtration rate (eGFR) \\>60 mL\u002Fmin\n* Glycated hemoglobin (HbA1c) ≤8%\n* Participants who are treatment-naïve, receiving metformin monotherapy, or receiving dual glucose-lowering therapy\n* Participants who agree to take part in the study\n\nExclusion Criteria:\n\n* Participants receiving treatment with three glucose-lowering medications\n* Participants receiving insulin therapy\n* Pregnancy\n* Breastfeeding\n* Chronic conditions such as HIV infection, cancer, or rheumatologic diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA)\n* Body mass index (BMI) ≥45 kg\u002Fm²\n* Concurrent participation in another research study","65 Years",{"count":146,"type":23},154,"OBSERVATIONAL","This prospective observational study will evaluate whether the SLC16A11 risk variant influences the response to metformin in adults with type 2 diabetes. Participants will be classified as carriers or noncarriers and followed for 6 months while receiving extended-release metformin titrated to the maximum tolerated dose, between 1,500 and 2,250 mg\u002Fday. The primary outcome is the change in glycated hemoglobin, with additional assessment of seven-point capillary glucose profiles, liver enzymes, visceral fat, lipid profile, and lactate concentrations. The study plans to include 154 participants to compare treatment response between both genetic groups and explore the potential value of a more personalized therapeutic approach.",[29],[151,152,153,72],"diabetes type 2","metformin","SLC16A11","2026-08-10",{"date":156,"type":45},"2026-08-12",{"date":158,"type":45},"2020-09-23",{"date":160,"type":23},"2027-12",{"name":162,"class":81},"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":18,"minAge":61,"maxAge":91,"enrollmentInfo":172,"targetDuration":4,"studyType":24,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":107},"100541892","harnessing-macrophage-lysosomal-lipid-metabolism-in-obesity-100541892","NCT06335771","Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity","Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases","ATM","Inclusion Criteria :\n\n* age: ≥18 but ≤70 years\n* not pregnant or breastfeeding\n* weight stable and sedentary before enrollment\n* no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \\[MAO\\]-Type 2 Diabetes group)\n* no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer)\n* participants must fulfil all of the following group-specific inclusion criteria below:\n\nLean group:\n\n* Body mass index (BMI) ≥18.5 but \\\u003C25.0 kg\u002Fm2\n* Intrahepatic triglyceride (IHTG) content \\\u003C5%\n* fasting blood glucose concentration: \\\u003C100 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: \\\u003C140 mg\u002Fdl\n* Hemoglobin A1C (HbA1c) \\\u003C5.7 %\n\nMetabolically normal obesity (MNO) group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* IHTG content \\\u003C5%\n* fasting blood glucose concentration: \\\u003C100 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: \\\u003C140 mg\u002Fdl\n* HbA1c \\\u003C5.7 %\n\nMetabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* IHTG content \\>7.5%\n* fasting blood glucose concentration: ≥100 but \\\u003C126 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \\\u003C200 mg\u002Fdl\n* HbA1c: ≥5.7 but \\\u003C6.4 %\n\nMAO-type 2 diabetes group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \\>126 mg\u002Fdl or blood glucose concentration 2 h after a 75 g oral glucose challenge\\>200 mg\u002Fdl or HbA1c \\>6.4 % without medication if not diagnosed and medically treated for diabetes\n\nExclusion Criteria:\n\n\\- Individuals that do not meet all inclusion Criterion",true,{"count":173,"type":23},60,[26],"The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.\n\nBoth groups will have:\n\n* screening visit\n* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \\[MRI\\] and magnetic resonance spectroscopy \\[MRS\\] scans)\n* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.",[177,178,29,179],"Obesity","Nonalcoholic Fatty Liver","Healthy","2026-08-03",{"date":182,"type":45},"2026-08-06",{"date":184,"type":45},"2024-08-01",{"date":186,"type":23},"2028-03",{"name":188,"class":81},"Bettina Mittendorfer",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":171,"sex":18,"minAge":61,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":24,"phases":199,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":107},"100444781","phase-1-pharmacogenetics-of-response-to-glp1r-agonists-100444781","NCT05071898","Pharmacogenetics of Response to GLP1R Agonists","PORT","Inclusion Criteria:\n\n* BMI greater than or equal to 27 kg\u002Fm2\n* Of Amish Descent\n\nExclusion Criteria:\n\n* Woman of childbearing age who is sexually active\n* History of diabetes (HbA1c \\> 6.5% or random glucose \\>200 mg\u002FdL)\n* Known allergy to semaglutide\n* Medical issues, which in the judgment of the research physician or PIs might increase the risk associated with participation in the study\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 sq. m.\n* Hematocrit \\\u003C 35%\n* TSH \\\u003C 0.4 o4 \\> 5.5\n* AST or ALT in excess of 2X the upper limit of normal\n* Unable to discontinue a drug, vitamin, or nutritional supplement, which in the judgment of the research physician or PIs might alter the response to semaglutide\n* Personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia, type 2","89 Years",{"count":198,"type":23},600,[200],"PHASE1","Overweight\u002Fobese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims:\n\n1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug).\n2. Specific Aim #2. To identify genetic variants associated with the effect of a GLP1R agonist to accelerate the rate of glucose disappearance as assessed in the two FSIGTs (before and after administration of drug).\n\nGenotyping will be conducted using a high-density array with comprehensive coverage of DNA sequence variants. In addition, the analysis will leverage a global imputation panel generated from 1,025 Amish individuals.",[177,29],[204,205,206,207,208],"GLP-1 receptor agonist","Insulin secretion","Insulin sensitivity","Pharmacogenomics","Semaglutide","2026-07-24",{"date":211,"type":45},"2026-07-27",{"date":213,"type":45},"2022-04-11",{"date":215,"type":23},"2028-04",{"name":217,"class":81},"University of Maryland, Baltimore",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":24,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":107},"100509378","enhancing-diabetes-management-approaches-for-patients-with-uncontrolled-diabetes-100509378","NCT05912647","Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes","A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes","ENRxICH","Inclusion Criteria:\n\n* Men and women ages 18-90 with diagnosed type 2 diabetes who speak and understand English or Spanish.\n* Taking at least one oral or injectable diabetes medication\n* HbA1c ≥ 7.5% based on point of care test.\n* Will reside in the geographical area throughout the study period.\n* Have access to a phone during the study period.\n* Willing to attend all orientation\u002Ftraining sessions.\n\nExclusion Criteria:\n\n* Having a caregiver who is the main decision maker in self-management.\n* Participating in another lifestyle, or medication adherence program.\n* Participated in standard MTM\u002FMTM-related intervention in the last 6 months.\n* Women who are pregnant or plan to get pregnant in the next 6 months.","90 Years",{"count":228,"type":23},376,[26],"The purpose of the study is to learn about the best way to enhance pharmacy-related care for diabetes self-management.\n\nThis research is being done because we want to improve use of medicines and diabetes management among adults with type 2 diabetes and find out which of type of support may improve diabetes self-management for adults.\n\nParticipants will be assigned to one of 4 groups, and will either:\n\n* receive care as usual; or,\n* receive added medicine management support from a pharmacist; or,\n* receive support from a Community Health Worker (CHW) to address life challenges; or,\n* receive both the pharmacist medicine management and the CHW support",[30,29],"2026-07-21",{"date":234,"type":45},"2026-07-23",{"date":236,"type":45},"2024-02-03",{"date":238,"type":23},"2027-12-01",{"name":240,"class":81},"University of Wisconsin, Madison",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":107},"100637770","changing-outpatient-diabetes-care-with-remote-patient-monitoring-a-real-world-evidence-study-with-pre-post-comparison-100637770","NCT07617519","Changing Outpatient Diabetes Care With Remote-Patient-Monitoring: A Real World Evidence Study With Pre-Post Comparison","Inclusion Criteria:\n\n* All people with active clinical care at SDCC during each period and thereby included in the RPM.\n\nExclusion Criteria:\n\n* All people without active clinical care at SDCC during each period.",{"count":248,"type":23},12000,"The goal of this observational pre-post study is to evaluate a remote-patient-monitoring-system (RPM-system) integrated within an electronic health record (EHR) system in a real world cohort of approximately 12.000 people with diabetes in an outpatient care setting. The main question it aims to answer is:\n\nWhether glycemic outcomes following integration of the RPM system into the EHR over a two-year period are non-inferior compared with outcomes observed prior to an ambulatory care restructuring (including a prototype of the RPM-system) in October 2024.\n\nParticipants are included in the RPM-system as part of their regular medical care for diabetes.",[30,251,252,29,253,254],"Diabetes Care","Diabetes Type 1","Remote Patient Monitoring","Digital Health","2026-07-15",{"date":257,"type":45},"2026-07-17",{"date":259,"type":45},"2026-06-10",{"date":261,"type":23},"2028-07",{"name":263,"class":81},"Steno Diabetes Center Copenhagen",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":91,"enrollmentInfo":271,"targetDuration":4,"studyType":24,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":107},"100646612","glucose-understanding-integrated-digital-health-and-engagement-guide-study-100646612","NCT07689877","Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study","GUIDE","Inclusion Criteria:\n\n* diagnosis of T2D for at least one year\n* recent 3 month-HbA1c, 8-11%\n* ownership of a smartphone\n* English or Spanish speaking.\n\nExclusion Criteria:\n\n* pregnant\n* not available or willing to use CGM or study device\u002Fplatform\n* serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia)\n\nIn addition to the self-report of the HbA1c within the past 3 months, potential participants will be screened with a point-of-care (POC) HbA1c (A1CNow®+).",{"count":272,"type":23},300,[26],"The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.",[30,29],"2026-07-01",{"date":278,"type":45},"2026-07-08",{"date":280,"type":23},"2026-08",{"date":282,"type":23},"2031-03",{"name":284,"class":81},"Yale University",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":24,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":107},"100641925","an-online-lifestyle-program-with-an-ai-lifestyle-coach-and-continues-glucose-monitoring-in-type-2-diabetes-100641925","NCT07661381","An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes.","\"An Online Personalised Lifestyle Program With a Virtual AI Lifestyle Coach in Combination With Continues Glucose Monitoring for People With Type 2 Diabetes.\"","PREVAIL","Inclusion Criteria:\n\n* Age: ≥18 years\n* HbA1c: ≥53 mmol\u002Fmol (7 - 12%)\n* Signed informed consent form and willing to comply with the study procedures\n* Persons who are naïve for participation in a lifestyle program for the past two years\n* Being digitally competent\n* Mastering the Dutch language\n* Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years)\n\nExclusion Criteria:\n\n* Medication use: any other glucose-lowering medication than metformin\n* Comorbidities or medical conditions requiring a special diet that conflicts with the study\n* Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight)\n* Circumstances that lead to unreliable HbA1c values, such as blood donation\n* Pregnant or lactating women",{"count":294,"type":23},160,[26],"The aim of this study is to evaluate the feasibility and effectiveness of a remote personalised lifestyle program in individuals with T2D. Outcomes will be assessed at the start and after 3, 6, and 12 months with two follow-up measurements (18 and 24 months) to determine whether participation in this re-mote lifestyle program leads to improvements in health and diabetes-related outcomes.",[29],[299,300,301,302,303,304],"Lifestyle intervention","Artificial intelligence","Remote study","Dietary intake","Continuous glucose monitoring","Lifestyle coach","2026-06-22",{"date":307,"type":45},"2026-06-25",{"date":309,"type":23},"2026-09",{"date":311,"type":23},"2028-12",{"name":313,"class":81},"University of Twente",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":171,"sex":18,"minAge":90,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":24,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":107},"100621902","effect-of-the-thrive-ai-health-app-on-lifestyle-behaviors-and-quality-of-life-100621902","NCT07376655","Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life","Inclusion Criteria:\n\n* Be at high risk for chronic disease defined as:\n\nBody mass index (BMI)\\>25\n\nBMI\\\u003C=25 who are prediabetic or have type 2 diabetes\n\n* Aged 40 years or older\n\nExclusion Criteria:\n\n* Unable to walk",{"count":321,"type":23},20,[26],"The goals of this randomized trial is to learn:\n\n1. If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep).\n2. How often participants will use the Thrive AI Health app to which they will have free access\n\nThe Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well.\n\nResearchers will compare changes in diet, exercise and sleep in participants using the app to those participants not using the app.\n\nParticipants will complete study questionnaires and an in-person visit at the beginning and end of the study.",[29,325],"Overweight or Obesity",[327,328,329,330],"Health app","Diet","Exercise","Sleep","2026-06-15",{"date":333,"type":45},"2026-06-17",{"date":335,"type":45},"2026-06-04",{"date":337,"type":23},"2027-04",{"name":284,"class":81},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":24,"phases":348,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":361,"locationsCount":363},"100471222","dulce-digital-20---innovative-diabetes-self-management-in-the-digital-age-100471222","NCT05416060","Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age","Dulce Digital","Inclusion Criteria:\n\n* Hispanic\u002FLatino adults who are registered patients of Scripps Health\n* Diagnosis of Type 2 Diabetes\n* HbA1c greater than or equal to 8% within the last 60 days\n\nExclusion Criteria:\n\n* Severe illness precluding visits to clinic\n* Liver function tests (ALT and AST) \\> 3 times the upper limit of normal\n* Body mass index ≤ 23 kg\u002Fcm\n* History of malignancy, except subjects who have been disease-free for \\>2 years, or whose only malignancy has been basal or squamous cell skin carcinoma\n* Creatinine \\>3.5\n* History of drug or alcohol abuse within 12 months prior to randomization\n* Current enrollee in DSME\u002FS\n* Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening\n* Anemia\n* Lack of minimal literacy needed to participate in the text intervention\n* Severe auditory or visual problems\n* Primary language other than Spanish or English\n* Not willing to carry a mobile phone\n* Pregnant\n* Plans to relocate",{"count":347,"type":23},150,[26],"The proposed research, \"Dulce Digital 2.0,\" will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk adults with diabetes. Expanding access to care in populations faced with challenges of low socioeconomic status and health literacy is a step toward reducing health disparities and positively affecting care. The literature shows that identifying which groups of participants are most likely to benefit from telehealth interventions is an important factor in improving the evidence base for digital health literacy. Dulce Digital 2.0 is highly scalable once the technical infrastructure is built. More importantly, by helping to reduce existing inequities in access to diabetes care and accurate digital health information the model could help to improve health outcomes on a larger scale. The use of digital technology in the delivery of healthcare interventions is increasingly common. Barriers to engagement in digital technology exist among those in underserved populations due to language, access to equipment and internet, education level, exposure to and comfort with technology, and pre-existing deficits in health literacy. The proposed research will investigate the effectiveness of two digital approaches to improving the self-management and digital health skills of underserved participants with diabetes compared to tradition in-person self-management education: 1) live self-management education, traditional in-person classes; 2) live self-management education using a telehealth distance learning platform; and 3) a series of text-based messages, not requiring a smart phone or internet connection, that encourage healthy self-management behaviors.",[29],[30,352,353,354,355,356],"Health Education","mHealth Technology","Group Education","Telehealth","Text-Based",{"date":333,"type":45},{"date":359,"type":45},"2023-03-23",{"date":104,"type":23},{"name":362,"class":81},"Scripps Whittier Diabetes Institute",2,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":373,"conditions":374,"keywords":380,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":107},"100639891","impact-of-glp-1-receptor-agonists-on-dry-eye-disease-in-patients-with-type-2-diabetes-mellitus-and-obesity-100639891","NCT07605572","Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity","GALENOS","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs).\n3. Patients able to provide informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding patients.\n2. History of multiple severe hypoglycemic episodes within the past two years.\n3. Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.\n4. Patients who have undergone cataract surgery or vitrectomy within the past 6 months.\n5. History of ketoacidosis or metabolic acidosis.\n6. History of corneal transplantation.",{"count":372,"type":23},100,"Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.",[375,376,377,378,29,379],"Dry Eye Disease (DED)","Diabete Mellitus","GLP-1","Ocular Surface","Cornea",[381,29,382,379],"Dry eye disease","GLP-1 Receptor Agonists","2026-05-29",{"date":385,"type":45},"2026-06-02",{"date":387,"type":45},"2026-03-01",{"date":389,"type":23},"2027-02-28",{"name":391,"class":81},"Attikon Hospital",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":20,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":401,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":107},"100603362","continuous-glucose-monitoring-cgm-in-an-underserved-population-100603362","NCT07135531","Continuous Glucose Monitoring (CGM) in an Underserved Population","Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications","Inclusion Criteria:\n\n* Age 18-75 years\n* Type 2 diabetes mellitus\n* HbA1C ≥ 7.5%\n* At least on 1 insulin injection therapy daily\n* Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas\n* Patients with Medicaid or free care or uninsured\n* Patients must be able to speak and understand English and be capable of providing informed consent to participate in the study\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Currently on CGM or using insulin pump\n* Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) \\\u003C40\n* Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate\n* The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement\n* Pregnant",{"count":400,"type":23},50,[26],"The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this population before doing a larger multicenter trial.",[30,404,29],"Diabetes Mellitus",[406,407,303,408],"Medicaid","Underinsured","Uninsured","2026-05-03",{"date":411,"type":45},"2026-05-05",{"date":413,"type":45},"2026-03-19",{"date":415,"type":23},"2027-07",{"name":417,"class":81},"Tulane University",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":24,"phases":428,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":107},"100472069","phase-2-canagliflozin-targeting-vascular-inflammation-100472069","NCT05427084","Canagliflozin Targeting Vascular Inflammation","Canagliflozin Targeting Vascular Inflammation: An Ottawa Imaging Study - A Pilot Study","CANTORSING","Inclusion Criteria:\n\n* 1\\) Stable CAD (over 60 days post-myocardial infarction).\n* 2\\) Diabetes\n* 3\\) given informed consent.\n\nExclusion Criteria:\n\n1. severe LV dysfunction (EF\\\u003C50%);\n2. decompensated heart failure;\n3. active infection (e.g. pneumonia, active skin infections, and on antibiotics);\n4. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));\n5. pregnancy (all women of child bearing potential will have a negative BHCG test;\n6. breastfeeding;\n7. Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.\n8. glomerular filtration rate (GFR) \\\u003C50 ml\u002Fmin\u002F1.72m2;\n9. Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);\n10. Hemoglobin \\\u003C 105(women) \\\u003C110 (men) g\u002FL; WBC \\\u003C 3.0x 10(9)\u002FL, platelet count\\\u003C 110x 10(9)\u002FL;\n11. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.\n12. unable to give informed consent;",{"count":427,"type":23},24,[429,430],"PHASE2","PHASE3","CANTOR SING is a pilot single center double blinded randomized study. The investigators will compare the effect of canagliflozin (300 mg daily - intervention arm) vs. placebo (control group) on the FDG aortic uptake in patients with stable CAD (over 60 days post-myocardial infarction) after a 6-month period of treatment. The investigators plan to enroll 8 patients in each arm (total sample size: 16 patients). Primary endpoint is the change in FDG aortic uptake between baseline and 6 months in each arm.",[29,433],"Coronary Artery Disease","2026-04-30",{"date":436,"type":45},"2026-05-06",{"date":438,"type":45},"2024-11-15",{"date":440,"type":23},"2026-12",{"name":442,"class":81},"Ottawa Heart Institute Research Corporation",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":90,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":24,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":462,"locationsCount":107},"100597739","enhancing-diabetes-care-by-treating-insomnia-100597739","NCT07062406","Enhancing Diabetes Care by Treating Insomnia","Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes","Inclusion Criteria:\n\n* aged 40 or older\n* receive primary care from participating clinic\n* diagnosis of type 2 diabetes\n* most recent hemoglobin A1c (HbA1c) \\>7% within the past year\n* Insomnia Severity Index (ISI) score ≥15\n* able to speak English\n\nExclusion Criteria:\n\n* diagnosed or self-reported sleep apnea\n* pregnant or planning to become pregnant during the study period\n* having a psychiatric or medical condition that would interfere with the ability to complete study procedures\n* participating in another diabetes clinical trial\n* living in same household as another participant\n* required to work night shifts",{"count":451,"type":23},30,[26],"Insomnia is highly prevalent in individuals with type 2 diabetes (T2D) and is associated with poor glycemic control. Louisiana has one of the highest diabetes prevalence rates in the U.S., with significant disparities by race, income, and rural residence. Despite growing recognition of sleep's role in diabetes management, sleep disturbances remain largely unaddressed in diabetes care. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia, yet it is underutilized in primary care clinics such as federally qualified health centers (FQHCs) that serve high-risk populations.\n\nThe long-term goal of this research is to improve cardiometabolic health and reduce diabetes disparities by integrating sleep interventions into diabetes care. This pilot study aims to: (1) evaluate the impact of CBT-I on sleep and diabetes-related outcomes, and (2) assess the acceptability, feasibility, and fidelity of implementing a 6-week CBT-I program in an FQHC setting.\n\nThe investigators will conduct a randomized controlled trial (RCT) with 30 FQHC patients (aged 40+) with uncontrolled T2D (HbA1c \\>7%) and comorbid insomnia (Insomnia Severity Index (ISI) score ≥15). Participants will be randomly assigned to either the CBT-I intervention or usual care. Sleep (ISI scores, actigraphy) and cardiometabolic (HbA1c, fasting glucose, insulin) outcomes will be assessed at baseline and three months post-randomization. Implementation success will be evaluated using fidelity, feasibility, and acceptability measures. Findings will provide preliminary evidence for integrating CBT-I into primary care, informing larger trials to improve diabetes outcomes and reduce disparities in Louisiana.",[29,455],"Insomnia","2026-04-20",{"date":458,"type":45},"2026-04-22",{"date":460,"type":23},"2026-06-01",{"date":389,"type":23},{"name":417,"class":81},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":171,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":472,"conditions":473,"keywords":477,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":107},"100606533","pregnancy-and-postpartum-breastfeeding-support-for-patients-with-gestational-diabetes-100606533","NCT07176793","Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes","Preventing Type 2 Diabetes Following Gestational Diabetes: Implementation Mapping for a Multilevel Breastfeeding Support Strategy","Inclusion Criteria:\n\n* ≥18 years old and able to communicate in English\n* Fits into one of the following:\n\n  1. patients with GDM who are recently pregnant and\u002For postpartum;\n  2. health care providers (nurses, physicians, lactation consultants, etc.) who would implement the strategy\n  3. executive leadership\n\nExclusion Criteria:\n\n* Subjects not meeting the inclusion criteria will be considered ineligible for participation",{"count":471,"type":23},10,"The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.",[474,29,475,476],"Gestational Diabetes Mellitus (GDM)","Breastfeeding Continuation","Breastfeeding Support",[478,479,480,481,482,483],"Gestational Diabetes","Preventing Diabetes Type 2 after GDM","Breastfeeding","Focus Groups","Implementation mapping","Breastfeeding support strategy","2026-04-01",{"date":486,"type":45},"2026-04-07",{"date":488,"type":45},"2026-03-23",{"date":490,"type":23},"2026-06-30",{"name":492,"class":81},"University of California, Davis",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":24,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":4},"100632225","cgm-in-acute-ischemic-stroke-100632225","NCT07510919","CGM in Acute Ischemic Stroke","Continuous Glucose Monitoring for Enhanced Management of Hyperglycemia in Persons With Type 2 Diabetes Undergoing Endovascular Therapy for Acute Ischemic Stroke: a Randomized Controlled Trial.","SENSTROKE","Inclusion Criteria:\n\n* Age ≥18 years\n* Acute ischemic stroke treated with endovascular therapy (EVT)\n* Type 2 diabetes mellitus, defined as one of the following:\n* documented diagnosis of type 2 diabetes mellitus\n* use of glucose-lowering medication\n* admission plasma glucose ≥11.1 mmol\u002FL\n* HbA1c ≥48 mmol\u002Fmol (≥6.5%)\n\nExclusion Criteria:\n\n* Current pregnancy\n* Extensive skin infections or dermatological conditions at the intended sensor site\n* Medical situations known to interfere with CGM accuracy, including:\n* Hypotension defined as a systolic blood pressure \\\u003C100 mmHg at 30 and 60 minutes after admission\n* Dialysis treatment\n* Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m²\n* Use of medications known to interfere with CGM accuracy, including:\n* Acetaminophen \\>4 g\u002Fday\n* Dopamine\n* High-dose vitamin C (ascorbic acid)\n* Hydroxyurea \u002F hydroxycarbamide\n* Clinically relevant pancreatic disease\n* Systemic glucocorticoid therapy with a prednisone-equivalent dose \\>5 mg\u002Fday\n* Expected admission to an intensive care unit (ICU)",{"count":502,"type":23},82,[26],"The goal of this randomized clinical trial is to evaluate whether continuous glucose monitoring (CGM) can be used to guide glucose management in patients with type 2 diabetes who are admitted with an acute ischemic stroke and undergo endovascular therapy. Hyperglycemia frequently occurs during hospitalization in stroke and is associated with worse neurological and clinical outcomes. In current clinical practice, glucose levels are monitored using intermittent point-of-care testing (POCT) with finger-prick measurements, which may miss clinically relevant glucose fluctuations. CGM provides continuous glucose measurements and may allow earlier detection of hyperglycemia and more timely glucose management.\n\nThis study is designed as a non-inferiority randomized controlled trial comparing CGM-guided glucose management with standard POCT-guided glucose management. The primary objective is to determine whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (glucose \\>10 mmol\u002FL) during the first 72 hours of hospitalization.\n\nResearchers will compare CGM-guided glucose management to POCT-guided glucose management to evaluate whether CGM can be used as an alternative strategy to guide glucose control in hospitalized stroke patients.\n\nParticipants will:\n\n* Be randomly assigned to either CGM-guided glucose management or standard POCT-guided glucose management\n* Have their glucose levels continuously monitored (blinded in the POCT-guided group) during hospitalization\n* Receive glucose management according to the assigned monitoring strategy, based on the hospital insulin protocol",[506,31,29,507,508],"Acute Ischemic Stroke","Hyperglycemia","Stroke","2026-03-31",{"date":511,"type":45},"2026-04-06",{"date":513,"type":23},"2026-04",{"date":515,"type":23},"2028-08",{"name":517,"class":81},"Isala",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":24,"phases":529,"briefSummary":530,"conditions":531,"keywords":533,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":539,"leadSponsor":541,"locationsCount":363},"100630238","digital-support-for-reducing-salt-intake-among-patients-with-diabetic-kidney-disease-protocol-for-a-controlled-clinical-trial-100630238","NCT07485075","Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical Trial","SBI 2024-2026 STENO FOOD CONCEPT","StenoFOODApp","Inclusion Criteria:\n\n* Type 2 diabetes (ICD-10 DE11.x)\n* Age 18-74 years\n* BMI \\\u003C 35 kg\u002Fm²\n* eGFR 30-59 ml\u002Fmin and UACR \\> 30 mg\u002Fg\n* Stable medication for ≥3 months\n* Ability to read and understand Danish\n\nExclusion Criteria:\n\n* Type 1 diabetes or other diabetes types\n* Current vegan diet\n* Active cancer\n* Short bowel syndrome or celiac disease\n* Use of sodium chloride tablets\n* No access to digital platform (intervention group only)","74 Years",{"count":528,"type":23},104,[26],"This study evaluates whether a digital patient education program can improve adherence to KDIGO 2022 dietary recommendations (low sodium and optimal protein intake) among patients with type 2 diabetes and chronic kidney disease (eGFR 30-59 ml\u002Fmin).",[29,532],"Kidney Disease",[534],"Type 2 Diabetes, Chronic Kidney Disease, Digital Health, Dietary Intervention, KDIGO Guidelines","2026-03-16",{"date":537,"type":45},"2026-03-20",{"date":537,"type":23},{"date":540,"type":23},"2027-12-31",{"name":263,"class":81},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":24,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":107},"100538877","enhancing-digitally-delivered-diabetes-education-with-real-time-cgm-100538877","NCT06296550","Enhancing Digitally Delivered Diabetes Education With Real-Time CGM","Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Are not currently using a CGM\n* Are not using insulin therapies\n* Speak English, Spanish or Arabic\n* Have A1c between 7.5% and 12.0% in last 90 days\n* Have a cellphone that can receive\u002Fsend text messages and counts steps\n\nExclusion Criteria:\n\n* Are using insulin therapies\n* Are pregnant\n* Are currently using a CGM\n* Are currently participating in another diabetes-related study",{"count":550,"type":23},140,[26],"The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.",[29],[30,555,556],"CGM","Diabetes Education","2026-03-04",{"date":559,"type":45},"2026-03-06",{"date":561,"type":45},"2025-04-03",{"date":563,"type":23},"2027-04-30",{"name":362,"class":81},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":171,"sex":18,"minAge":573,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":597},"100621752","disentangling-the-effect-of-brain-insulin-resistance-on-brain-health-100621752","NCT07374705","Disentangling the Effect of Brain Insulin Resistance on Brain Health","Disentangling the Effect of Brain Insulin Resistance on Brain Health (BIR-BrainHealth)","BIR 1","Inclusion Criteria (all):\n\n* age 50-80 years\n\nInclusion Criteria (diabetes only):\n\n* Diagnosis of either type 1 diabetes or type 2 diabetes\n* Diabetes duration of ≥10 years for individuals with type 1 diabetes and ≥5 years for individuals with type 2 diabetes\n\nExclusion Criteria:\n\n* HbA1c \\>100 mmol\u002Fmol\n* Other type of diabetes\n* Weight \\>140 Kg\n* Treatment with drugs that cannot be paused for 12 hours\n* Diagnosis of dementia\n* Active and recent (1year) malignant disease\n* History of major stroke\n* Major depression and\u002For treatment with antipsychotics\n* History of traumatic brain injury\n* Other medical condition or disorder (e.g., epilepsy, recent concussion) that in the opinion of the investigator precludes compliance with the protocol, evaluation of the results or represent an unacceptable risk for the participant's safety.\n* Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that cannot be improved with aids such as glasses and hearing aids, or language barrier.)\n* Severe claustrophobia\n* Foreign bodies of metal in the body which prohibits brain MRI scans (e.g. pacemaker or screws\u002Fplates from surgery in the head or neck region)\n* Participants who do not wish to be informed about accidental findings by MRI\n* eGFR measurement \\\u003C45 within 3 months of study visit","50 Years","80 Years",{"count":347,"type":23},"People with diabetes are at increased risk of developing dementia, including Alzheimer's disease and vascular dementia. In addition, persons with diabetes have more pronounced age-related brain atrophy and cognitive difficulties compared to people without diabetes. The mechanisms behind the effects on the brain of diabetes are still unclear. New research suggests that the brains of some people with diabetes do not respond normally to insulin signals, a condition known as brain insulin resistance (BIR). To date, there have been no large clinical studies investigating BIR and its impact on brain health, but several smaller studies suggest that BIR may be a cause of cognitive decline and impaired brain health in people with diabetes. Another mechanism that may contribute to impaired brain health in people with diabetes is damage to the blood vessels in the brain. Damage to blood vessels is a well-known complication of diabetes, but how it affects the brain is not fully described. In this project, we will investigate the relationship between BIR and brain blood vessel dysfunction and its relationship to cognition and brain function. This is done by examining patients with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy controls. The participants will undergo MRI brain scans to assess the impact of BIR on the brain physiology and to evaluate brain blood vessel health. Participants will undergo comprehensive assessments of their cognitive abilities and thorough health examination.",[29,252],[30,579,580,581,582,583,584,585,586,151,587],"Brain Insulin Resistance","cognitive performance","cognitive dysfunction","structural changes in the brain","cerebrovascular function","brain health","blood-brain-barrier","diabetes type 1","biomarkers","2026-02-24",{"date":590,"type":45},"2026-02-25",{"date":592,"type":45},"2026-01-01",{"date":594,"type":23},"2032-01",{"name":596,"class":81},"Henrik Bo Wiberg Larsson",3,{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":115,"minAge":61,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":24,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":618,"leadSponsor":619,"locationsCount":107},"100609871","fellaship-to-better-health-100609871","NCT07220213","FELLAShip to Better Health","Inclusion Criteria:\n\n* Self-identified Black men\n* Age 18 or older\n* LE8 (Life's Essential 8) score (threshold not specified, but implies \"less than ideal\" CVH)\n* English speaking\n* Resides in the Metropolitan Birmingham, Alabama area\n* No physical activity restrictions imposed by a healthcare provider\n\nExclusion Criteria:\n\n* Not identifying as Black and male\n* Under age 18\n* Non-English speakers\n* Not living in the Birmingham, Alabama metro area\n* Having a healthcare provider-imposed restriction on physical activity\n* Ideal CVH (i.e., LE8 (Life's Essential 8) score above inclusion threshold)",{"count":605,"type":23},90,[26],"The goal of this clinical trial is to evaluate the implementation and effectiveness of the FELLAship program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are:\n\n* Does participation in the FELLAship program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)?\n* What factors influence the adoption, delivery, and sustainability of the FELLAship program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors.\n\nParticipants will:\n\n* Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches.\n* Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care.\n* Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes.\n* Use a smartwatch, blood pressure cuff, and other tools to track progress in real time.\n* Participate in exit focus groups or interviews to share feedback about the intervention.\n* A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability.\n\nThis study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.",[609,610,611,612,613,29],"High Blood Glucose","High Cholesterol","High Cholesterol\u002FHyperlipidemia","Blood Sugar; High","Obesity & Overweight","2026-01-21",{"date":616,"type":45},"2026-01-22",{"date":592,"type":45},{"date":47,"type":23},{"name":620,"class":81},"University of Alabama at Birmingham",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":171,"sex":18,"minAge":629,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":24,"phases":632,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":107},"100619905","engagement-of-community-through-participatory-learning-and-action-for-control-and-prevention-of-type-ii-diabetes-and-its-risk-factors-100619905","NCT07350694","Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors","Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D-Afg]: Feasibility Trial in Rural Kabul-Afghanistan","EMPOWER-D-Afg","Inclusion Criteria:\n\n* For intervention phase: Individuals aged 20 years and above. For baseline and endline assessments (before and after the intervention): Individuals aged 30 years and above.\n* Participants residing in the randomized clusters of Kabul, Afghanistan Individuals willing to participate in the study and provide consent.\n* All individuals with normoglycemia, intermediate hyperglycaemia, and diabetes are encouraged to participate.\n* Participants who can attend the scheduled meetings and interventions as per the study protocol.\n\nExclusion Criteria:\n\n* For Intervention phase: Individuals below the age of 20 years. For baseline and endline assessments (before and after the intervention): individuals below the age of 30 years.\n* Individuals unwilling to provide consent for participation.\n* Participants with reported health conditions that may hinder their active involvement in the study.\n* Individuals with non-compliance with research protocols","20 Years",{"count":631,"type":23},250,[26],"This project aims to adapt, implement, and evaluate PLA based intervention in Rural Kabul, Afghanistan for TIIDM prevention and control.",[29,635],"Type II Diabetes Mellitus",[637,638,635,639],"Community-Based Participatory Research","Participatory Learning and Action Research","Intermediate hyperglycemia","2026-01-11",{"date":642,"type":45},"2026-01-20",{"date":644,"type":45},"2024-12-24",{"date":646,"type":23},"2027-09-30",{"name":648,"class":81},"HealthNet Transcultural Psychosocial Organization",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":656,"maxAge":144,"enrollmentInfo":657,"targetDuration":4,"studyType":24,"phases":659,"briefSummary":660,"conditions":661,"keywords":663,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":107},"100619926","magnetic-compression-anastomosis-procedure-for-partial-jejuno-ileal-diversion-evaluating-the-feasibility-of-a-novel-endoscopic-magnetic-metabolic-interventional-therapy-100619926","NCT07350967","Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy","2025\u002F08\u002FEMMIT","Inclusion Criteria:\n\n1. Participants are willing and able to give informed consent for participation in the study.\n2. Male or Female, aged ≥ 25 years to ≤ 65 years inclusive at the time of informed consent\n3. BMI 30-50\n\n   * Prior sleeve gastrectomy (\\> 12 months) or other metabolic surgical procedures with T2DM (characterized by HbA1c \\> 6.5%) or weight regain\n   * T2DM without a history of gastrectomy or other metabolic surgical procedures (diagnosis for \\> 6M and \\\u003C10 yrs) taking at least oral antidiabetic medication with fasting glucose \\\u003C 200mg\u002Fdl and HbA1c \\>6.5 %\n4. Agrees to abstain from any form of additional bariatric or reconstructive surgery that could influence body weight for a duration of 1 year\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months\n2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)\n3. Current enrolment in another research study or previous participation within 30 days of enrolment\n4. Use of injectable insulin\n5. Uncontrolled T2DM\n6. Uncontrolled hypertension, dyslipidemia, or sleep apnea\n7. Current history of injected Glucagon Like Peptide 1 (GLP1)\n8. Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies\n9. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging\n10. Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures\n11. Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures\n12. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum\n13. Refractory gastroesophageal reflux disease (GERD)\n14. Barrett's esophagus\n15. Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques\n16. Presence of an implantable pacemaker or defibrillator\n17. Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses any conditions for which endoscopic or laparoscopic surgery would be contraindicated, as well as any significant congenital or acquired anomalies of the gastrointestinal tract at or distal to the magnet placement site\n\nSubjects will be deemed ineligible to participate if they fulfill any of the following criteria:\n\n1\\. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months 2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.) 3. Current enrolment in another research study or previous participation within 30 days of enrolment 4. Use of injectable insulin 5. Uncontrolled T2DM 6. Uncontrolled hypertension, dyslipidemia, or sleep apnea 7. Current history of injected Glucagon Like Peptide 1 (GLP1) 8. Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies 9. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 10. Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures 11. Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures 12. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum 13. Refractory gastroesophageal reflux disease (GERD) 14. Barrett's esophagus 15. Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques 16. Presence of an implantable pacemaker or defibrillator 17. Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses any conditions for which endoscopic or laparoscopic surgery would be contraindicated, as well as any significant congenital or acquired anomalies of the gastrointestinal tract at or distal to the magnet placement site 18. History of small bowel surgery such as small bowel resection 19. Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.) 20. History of chronic or acute pancreatitis 21. Known active hepatitis or active liver disease 22. Symptomatic gallstones or kidney stones or acute cholecystitis 23. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia 24. Use of anticoagulation therapy (excluding aspirin) which cannot be discontinued for 7 days before and 14 days after the procedure 25. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure (use of low-dose aspirin allowable) 26. History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and\u002For diabetes-related soft tissue infection 27. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide) 28. Receiving weight loss medications such as Meridia, Xenical, or over-the-counter weight loss medications 29. Persistent anemia, defined as Hgb\\\u003C10 g dL-1 30. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) \\\u003C30 ml\u002Fmin\u002F1.73m2 31. Active systemic infection 32. Chemotherapeutic cancer treatment within past 9 months, history of abdominal radiation, or active malignancy within the past 5 years 33. Active illicit substance abuse or alcoholism 34. Unhealed ulcers, bleeding lesions, tumors, or any other lesions at the target site for magnet deployment 35. Anticipated requirement for MR imaging within the first two months following the procedure 36. Any anatomical anomaly that prevents or contraindicates laparoscopic access and general laparoscopic procedures 37. Underwent a surgical or interventional procedure within 30 days prior to the current procedure 38. Any scheduled surgical or interventional procedure planned within 30 days following the current procedure 39. Any stroke or transient ischemic attack (TIA) within six months prior to obtaining consent 40. Any other serological markers likely to be associated with poor outcomes 41. Inability to adhere to the follow-up schedule and assessments 42. Any circumstance that, according to the investigator's judgment, could hinder the completion of follow-up evaluations up to Day 360 (for instance, a health issue that might elevate the risks linked to study involvement or could obstruct the analysis of study findings, failure to comply with the visit timetable, or inadequate adherence to the treatment protocol)\n\n\\-","25 Years",{"count":658,"type":23},5,[26],"English, Hindi and Gujarati",[29,662],"Bariatric Surgery",[664],"Magnetic Compression Anastomosis","2026-01-09",{"date":642,"type":45},{"date":668,"type":45},"2025-11-11",{"date":670,"type":23},"2026-11-30",{"name":672,"class":52},"iIDEAS Group Holdings Limited","Diabetes, Type 2"]