[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-nephropathy-type-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-nephropathy-type-2":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,65,93,127,149,180,201,223,246],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100652146","phase-1-human-umbilical-cord-mesenchymal-stem-cell-infusion-for-type-2-diabetic-nephropathy-100652146",false,"NCT07769671","Human Umbilical Cord Mesenchymal Stem Cell Infusion for Type 2 Diabetic Nephropathy","Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection Via Intravenous Infusion in Type 2 Diabetic Nephropathy: A Phase I\u002FIIa Clinical Trial","Inclusion Criteria:\n\n* Aged 18 to 80 years, with no gender and ethnicity restrictions.\n* Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) as defined by the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition), with:\n\n  1. Baseline serum C-peptide concentrations ranging from 0.3 to 3.0 ng\u002FmL;\n  2. Stable antihyperglycemic and antihypertensive medication regimen for at least 3 months prior to screening, defined as dosage adjustment less than 25%.\n* Urinary albumin-to-creatinine ratio (UACR) ≥ 30 and ≤ 5000 mg\u002Fg together with estimated glomerular filtration rate (eGFR) ≥ 30 and \\\u003C 90 mL\u002Fmin\u002F1.73 m².\n* Patients are required to have renal biopsy-proven DN glomerulopathy with Tervaert Class IIa to Class III glomerular lesions.\n* Patients voluntarily agree to participate and provide written informed consent after full disclosure of the study's purpose, procedures, nature, and potential adverse reactions.\n\nExclusion Criteria:\n\n* Other non-T2DM, such as type 1 diabetes.\n* Individuals allergic to MSCs or their preservation solution.\n* Individuals with any of the following conditions during screening:\n\n  1. History of acute diabetic complications within the past 6 months, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis;\n  2. Unstable disease status or severe diabetic complications within the past 6 months, such as proliferative diabetic retinopathy or macular edema, severe diabetic neuropathy, intermittent claudication, active diabetic foot lesions;\n  3. History of three or more Level 3 hypoglycemic events within the past 6 months, as defined by the Guidelines for the Management of Type 2 Diabetes in China (2020 Edition);\n  4. History of any of the following cardiac conditions within the past 6 months: decompensated heart failure (New York Heart Association Class III-IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; severe arrhythmias requiring treatment, including second-degree or third-degree atrioventricular block, long QT syndrome, or QTc interval prolongation ≥ 500 ms, and deemed by the investigator to render the subject unsuitable for study participation;\n  5. History of hemorrhagic or ischemic stroke within the past 6 months deemed by the investigator to render the subject unsuitable for study participation;\n  6. History of other severe endocrine disorders affecting glucose metabolism, such as multiple endocrine neoplasia, acromegaly, and Cushing's syndrome, deemed by the investigator to render the subject unsuitable for study participation;\n  7. History of severe digestive system diseases, nutritional and metabolic disorders, or rheumatologic diseases, deemed by the investigator to render the subject unsuitable for study participation;\n  8. Concurrent malignancy or history of malignancy (except malignancies with at least 5 years of disease-free survival);\n  9. Severe psychiatric disorder or speech impairment, or the subject is unwilling or unable to fully understand and comply with study requirements;\n  10. Severe infection or major surgery within the past 6 months, deemed by the investigator to render the subject unsuitable for study participation;\n  11. Acquired Immunodeficiency Syndrome, active hepatitis B, hepatitis C infection, or other acute or chronic infectious diseases;\n  12. Poorly controlled blood pressure, defined as a systolic blood pressure \\> 180mmHg and\u002For diastolic blood pressure \\> 110mmHg.\n* Laboratory test results meet the following criteria:\n\n  1. Alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN);\n  2. Total bilirubin ≥ 2.0 times ULN;\n  3. Currently suffering from severe renal disease, or eGFR (CKD-EPI2012Scr-CysC) \\\u003C 30 mL\u002Fmin\u002F1.73 m²;\n  4. Fasting triglycerides \\> 5.6 mmol\u002FL;\n  5. Serum amylase or serum lipase ≥ 1.5 times ULN;\n  6. Hemoglobin \\\u003C 10.0 g\u002FdL (100 g\u002FL), serum albumin \\\u003C 30 g\u002FL;\n  7. Glycosylated hemoglobin ≥ 10%.\n* History of long-term systemic corticosteroid administration (consecutive or cumulative ≥ 7 days) within 1 month prior to screening (including but not limited to intravenous administration, oral administration, or intramuscular injection).\n* Renal replacement therapy within 3 months prior to screening, current ongoing, or planned initiation within the next 3 months (including hemodialysis, peritoneal dialysis, continuous renal replacement therapy).\n* Participation in other drug or device clinical trials within 3 months prior to screening.\n* Previous use of other stem cell treatments.\n* Use of immunosuppressants, tripterygium glycosides, eplerenone, spironolactone, or similar agents within 3 months prior to screening.\n* Pregnancy, lactation, or intention to become pregnant during the study period.\n* Any other condition that, in the investigator's judgment, would make the subject unsuitable for the study.\n* Renal biopsy revealing DN with coexisting non-DN pathology.","ALL","18 Years","80 Years",{"count":20,"type":21},49,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Diabetic nephropathy (DN) is a chronic kidney disease caused by diabetes. It is one of the most common and most serious microvascular complications of diabetes. Current treatment options for DN are limited. Mesenchymal stem cells (MSCs) are considered one of the promising treatments for DN. This study aims to evaluate the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN.",[28],"Diabetic Nephropathy Type 2","NOT_YET_RECRUITING","2026-08-12",{"date":32,"type":33},"2026-08-18","ACTUAL",{"date":35,"type":21},"2026-09-01",{"date":37,"type":21},"2029-08-31",{"name":39,"class":40},"The First People's Hospital of Changzhou","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100643005","phase-2-vitamin-d-in-diabetic-neuropathy-100643005","NCT07644520","Vitamin D in Diabetic Neuropathy","Effect of Vitamin D Supplementation on Neuropathic Pain, Sleep Quality, and Quality of Life in Patients With Diabetic Peripheral Neuropathy","Inclusion criteria\n\nParticipants must fulfill all the following:\n\n1\\. Age between 18 and 75 years 2. Diagnosed with type 2 diabetes mellitus according to ADA criteria 3. Clinically diagnosed diabetic peripheral neuropathy 4. Neuropathic symptoms for at least 3 months 5. Vitamin D insufficiency or deficiency:\n\n* Serum 25(OH)D \\\u003C 30 ng\u002FmL 6. Stable antidiabetic treatment for at least 3 months Exclusion criteria\n\n  1. Type 1 diabetes mellitus\n  2. Current vitamin D supplementation within the previous 3 months\n  3. Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n  4. Severe hepatic impairment\n  5. Hypercalcemia\n  6. Malabsorption syndromes\n  7. Pregnancy or lactation\n  8. Peripheral neuropathy due to causes other than diabetes:\n* Vitamin B12 deficiency\n* Hypothyroidism\n* Alcoholic neuropathy\n* Chemotherapy-induced neuropathy 9. Active malignancy 10. Severe psychiatric illness","65 Years",{"count":51,"type":21},150,[25,53],"PHASE3","Introduction Diabetic peripheral neuropathy (DPN) is among the most common chronic complications of diabetes mellitus and represents a major cause of morbidity, impaired quality of life, sleep disturbance, chronic pain, and functional disability.(Kurz et al., 2026) The pathogenesis of DPN is multifactorial and involves oxidative stress, chronic inflammation, endothelial dysfunction, mitochondrial injury, and microvascular ischemia, leading to progressive nerve damage.(Yang et al., 2025) Despite the availability of symptomatic therapies such as gabapentin, pregabalin, and duloxetine, many patients continue to experience persistent neuropathic symptoms, poor sleep quality, and impaired daily functioning. Existing pharmacological therapies are often associated with incomplete response, adverse effects, and high economic burden.(Kaye et al., 2025) Recently, vitamin D has attracted attention beyond its classical role in calcium and bone metabolism. Experimental and clinical evidence suggest that vitamin D possesses neuroprotective, anti-inflammatory, immunomodulatory, and antioxidative properties. Vitamin D receptors are widely distributed in neuronal tissues, Schwann cells, and immune cells, suggesting a potential role in nerve repair and modulation of neuropathic pain pathways.(Liu et al., 2025) Several observational studies have demonstrated a high prevalence of vitamin D deficiency among patients with diabetic neuropathy, and low serum vitamin D levels have been associated with increased neuropathic pain severity and poorer quality of life. However, available interventional studies remain limited and have produced inconsistent findings regarding the therapeutic benefit of vitamin D supplementation in DPN.(Ou et al., 2021) Therefore, this study aims to evaluate whether vitamin D supplementation can improve neuropathic pain, sleep quality, and health-related quality of life among patients with diabetic peripheral neuropathy.",[28],"2026-06-08",{"date":58,"type":33},"2026-06-12",{"date":60,"type":21},"2026-10-01",{"date":62,"type":21},"2027-10-30",{"name":64,"class":40},"Tanta University",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100628308","research-on-innovative-traditional-chinese-medicine-diagnosis-and-treatment-technologies-for-diabetic-nephropathy-driven-by-multi-omics-and-artificial-intelligence-100628308","NCT07459946","Research on Innovative Traditional Chinese Medicine Diagnosis and Treatment Technologies for Diabetic Nephropathy Driven by Multi-Omics and Artificial Intelligence","Research on New Diagnosis and Treatment Technologies for Major Traditional Chinese Medicine Advantage Diseases - Multi-Omics and Artificial Intelligence-Driven Innovative TCM Diagnosis and Treatment Technologies for Diabetic Nephropathy","Inclusion Criteria:\n\n1. Meets the clinical diagnostic criteria for diabetic nephropathy;\n2. Aged 18-75 years, any gender;\n3. eGFR \\>45 ml\u002Fmin\u002F1.73m²;\n4. 24-hour urine protein \\\u003C2.0 g\u002Fday;\n5. Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms;\n6. Willing to participate in the study, able to attend regular follow-ups, and provide informed consent;\n7. Has maintained a stable basic treatment plan (including hypoglycemic, antihypertensive, and lipid-lowering therapies) for ≥1 month prior to enrollment; during the first 3 months after enrollment, ARB, finerenone, and SGLT2 inhibitor therapies should generally not be adjusted.\n\nExclusion Criteria:\n\n1. Acute kidney injury or renal function impairment caused by other reasons (recent rapid decline in renal function, or kidney damage caused by drugs, infections, etc.);\n2. Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.);\n3. Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.);\n4. Critical organ failure (severe diseases of the heart, liver, or lungs);\n5. Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study);\n6. Drug allergy or clear contraindications (allergic to the study drug or its components);\n7. Non-cooperative or unable to follow the study protocol (unable or unwilling to comply with study requirements);\n8. Abnormal coagulation function, or undergoing anticoagulant therapy (such as warfarin, rivaroxaban, etc.) with bleeding risk;\n9. Currently taking Chinese herbal medicine or patent Chinese medicine with effects of tonifying deficiency, promoting blood circulation, or dispelling wind-dampness.","75 Years",{"count":74,"type":21},198,[76],"NA","With the help of the 'Traditional Chinese Medicine Specialty Alliance Platform-Multicenter RCT Clinical Research Database,' this platform can be used to conduct scientific research on various aspects of DKD, such as disease prediction, treatment effectiveness evaluation, and recurrence rate analysis, providing effective means to improve DKD remission rates, delay disease progression, and enhance patients' quality of life. By selecting the Jiade Yishen Xiaozheng Qufang formula and conducting multicenter, prospective, double-blind RCT studies, its clinical value in improving DKD remission rates can be verified. With the support of scientific research, DKD treatment strategies can be optimized, therapeutic efficacy improved, recurrence rates reduced, and disease progression delayed, thereby enhancing patients' quality of life.",[28,79],"Chronic Renal Failure\u002F Kidney Disease",[28,81,82,83],"Randomized Controlled Trial","Multi-omics analysis","Artificial Intelligence (AI) in Diagnosis","2026-03-04",{"date":86,"type":33},"2026-03-10",{"date":88,"type":21},"2026-03-12",{"date":90,"type":21},"2026-12-31",{"name":92,"class":40},"Jiazhen Yin",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":99,"maxAge":49,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":41},"100623401","phase-1-safety-and-efficacy-of-allogeneic-umbilical-cord-mesenchymal-stem-cell-therapy-in-diabetic-nephropathy-patients-a-clinical-trial-100623401","NCT07396155","Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial","Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes Mellitus (T2DM)\n* Aged between 40 and 65 years\n* Diagnosed with chronic kidney disease (CKD) stage III or IV, defined as estimated GFR (eGFR) between 15-60 mL\u002Fmin\u002F1.73 m² (using CKD-EPI formula)\n* Renal biopsy showing diabetic nephropathy type IIa-IV\n* Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg\u002Fg (spot morning urine sample)\n* Controlled diabetes, defined as HbA1c \\\u003C10.0% during screening\n* Blood pressure within the range of: Systolic 100-160 mmHg, Diastolic 60-100 mmHg\n* On stable standard therapy for diabetic nephropathy (e.g. ACE inhibitors or ARBs) for at least 12 weeks prior to screening\n* Willing to provide written informed consent and comply with all study procedures until completion\n\nExclusion Criteria:\n\n* Active malignancy or history of cancer\n* Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal)\n* Hemoglobin \\\u003C8 g\u002FdL or platelet count \\\u003C100,000\u002FµL\n* Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months\n* Positive pregnancy test or currently breastfeeding (for women of reproductive age)\n* Currently receiving immunosuppressive therapy equivalent to ≥20 mg\u002Fday prednisone\n* History of participation in other stem cell research or therapy studies","30 Years",{"count":5,"type":21},[24,25],"The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are:\n\n1. Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy?\n2. Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period?\n\nThis is a single-arm, open-label, prospective clinical trial. Participants will receive a one-time intra-renal injection of UC-MSC at a dose of 1 x 10⁶ cells\u002Fkg body weight.\n\nParticipants will attend scheduled follow-up visits at 1, 3, 6, 9, and 12 months post-injections for evaluation of:\n\n1. Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio)\n2. Inflammatory markers (TNF-α, IL-10)\n3. Safety outcomes including early and late adverse events\n\nThe results will be compared to baseline measurements to assess changes after the intervention.\n\nIf there is a comparison group: Researchers will compare \\[arm information\\] to see if \\[insert effects\\].\n\nParticipants will \\[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\\].",[28],[105,106,107,108,109,110,111,112,113,114,115],"Umbilical Cord Mesenchymal Stem Cell","Diabetic Nephropathy","Kidney Disease","Intra-renal Injection","TNF-alpha","IL-10","Glomerular Filtration Rate","eGFR","Regenerative Medicine","Mesenchymal Stem Cells","UC-MSC","RECRUITING","2026-02-03",{"date":119,"type":33},"2026-02-09",{"date":121,"type":21},"2026-07-01",{"date":123,"type":21},"2027-10",{"name":125,"class":126},"PT. Prodia Stem Cell Indonesia","INDUSTRY",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100569114","relationship-of-serum-zinc-level-with-severity-of-diabetic-nephropathy-100569114","NCT06690034","Relationship of Serum Zinc Level With Severity of Diabetic Nephropathy","Inclusion Criteria:\n\n* Patients with diabetic kidney disease\n\nExclusion Criteria:\n\n* patients on dialysis. Patient refuse to participate\n* Other renal disease \"lupus nephritis,GlomeruloNephritis",{"count":134,"type":21},92,"OBSERVATIONAL","Zinc influences the production and action of erythropoietin (EPO), a hormone produced by the kidneys that stimulates red blood cell production.\n\nHowever, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with Diabetic kidney disease. this study aim to detect serum zinc level in patient with Diabetic kidney disease \"CKD\" and Study of association between serum zinc and serum urea, creatinine, GFR, hemoglobin ,HbA1c in DKD",[28],[139],"serum zinc level","2024-11-13",{"date":142,"type":33},"2024-11-15",{"date":144,"type":21},"2025-12-01",{"date":146,"type":21},"2027-01-01",{"name":148,"class":40},"Assiut University",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100561134","clinical-utility-of-a-genomic-predictor-test-on-the-management-of-cardiorenal-complications-of-type-2-diabetes-100561134","NCT06586203","Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes","New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes","GENOCORDIA","Inclusion Criteria:\n\n* Adult patients with T2D of both sexes regardless of ethnicity, level of diabetes control and presence of complications.\n* Able to visit the study site 7 times\n* Able and willing to provide informed consent to the clinical and PRS parts of the study.\n\nExclusion Criteria:\n\n* Any condition that may impact participation in a real-world study according to the treating physician.\n* People with a high frailty index as no benefit of therapeutic intensification has been demonstrated in these diabetic patients.\n* People who refuse to be informed of their cardiorenal risk score.",{"count":158,"type":21},2714,[76],"The goal of this pragmatic trial is to provide Real World Evidence (RWE) on the impact of the result of a polygenic risk prediction test of cardiorenal complications of T2D, so that more patients at high risk of these complications achieve over an 18 months period, recommended therapeutic targets.\n\nThis will be demonstrated as a significant improvement in a composite value including HbA1c or systolic blood pressure (SBP) or albuminuria (UACR), or glomerular filtration rate (GFR) lowering.\n\nResearchers will compare the recommended therapeutic targets of uninformed and informed patients to see if the knowledge of the risk by the patients and their treating physicians improves achievement of these targets.\n\nParticipants will:\n\nHave a saliva sampling to determine the genetic risk. Visit the clinic once every 3 months for checkups and tests Answer two questionnaires on quality of life.",[162,163,28],"Diabetes Mellitus, Type 2","Cardiovascular Diseases",[162,165,166,167,168,169],"Cardiorenal complications","Polygenic risk scores","Therapeutic targets","Precision Medicine","Prevention","2024-09-05",{"date":172,"type":33},"2024-09-19",{"date":174,"type":33},"2024-08-23",{"date":176,"type":21},"2028-08-23",{"name":178,"class":126},"Optithera",2,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":41},"100533181","effect-of-dorzagliatin-on-renal-function-outcomes-in-people-with-type-2-diabetes-a-multicentric-prospective-randomized-study-100533181","NCT06222476","Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.","A Multicentric, Prospective, Randomized Study Evaluating the Improvement of Renal Function Outcomes With Dorzagliatin in Patients With Type 2 Diabetes Mellitus With Early Kidney Injury.","Inclusion Criteria:\n\n1. Age:18-75 years old, male and female.\n2. Patients with type 2 diabetes mellitus, type 2 diabetes mellitus diagnosis criteria: according to the \"Chinese Type 2 Diabetes Mellitus Prevention and Treatment Guide (2020 Edition).\n3. UACR 30-299mg\u002Fg.\n4. eGFR ≥60mL\u002Fmin\u002F1.73m².\n5. HbA1c 7.0-10.5%.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.\n2. Known allergic history to dorzagliatin\u002Fgliclazide\u002Fmetformin.\n3. Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.\n4. Serious impairment of heart, liver, kidney and other organs.\n5. With hypertension(≥140\u002F90mmHg).\n6. Fasting C-peptide \\\u003C300pmol\u002FL.\n7. Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.",{"count":188,"type":21},106,[76],"The main purpose of this study is to explore the improvement of renal function before and after the intervention of dorzagliatin in patients with type 2 diabetes.",[28],"2024-01-16",{"date":194,"type":33},"2024-01-24",{"date":196,"type":21},"2024-02-20",{"date":198,"type":21},"2026-06-30",{"name":200,"class":40},"Yan Bi",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":4},"100521349","phase-2-study-of-the-protective-effect-of-low-dose-aspirin-on-renal-function-in-patients-with-early-diabetic-nephropathy-100521349","NCT06068439","Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy","A Phase III Multi-center Randomized Placebo-controlled Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic","Inclusion Criteria:\n\n* 1.Voluntarily sign informed consent;2.Meet the diagnosis of diabetic nephropathy: In the case of identifying diabetes as the cause of kidney damage and excluding chronic kidney disease caused by other causes, at least one of the following is present:①. In the case of excluding interference factors, at least 2 UACR≥30mg\u002Fg or UAER≥30mg\u002F24h (≥20ug\u002Fmin) in 3 tests within 3\\~6 months. ②. eGFR\\\u003C60ml\u002Fmin\u002F(1.73m2)-1 for more than 3 months. ③. Renal biopsy consistent with pathological changes of DKD;3.DKD staging is 3 and before，eGFR\\>30ml\u002Fmin\u002F(1.73m2)-1；\n\nExclusion Criteria:\n\n* (1) History of cardiovascular or cerebrovascular events (defined by the patient's medical history and\u002For instrumental examination results); (2)Insufficient glycemic control (i.e., glycated hemoglobin ≥8%); (3) Uncontrolled blood pressure despite taking antihypertensive drugs (≥140\u002F≥85mmHg); (4) Previous major bleeding (i.e., intracranial hemorrhage); (5) Previous gastrointestinal ulcers; (6) Clinical diagnosis of type 1 diabetes mellitus (diagnosis of diabetes mellitus and use of insulin before age 35);(7) Patients with CKDG4 or G5 (i.e., eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m2 or dialysis) ;(8) chronic active infection or; (9) evidence of malignancy within the past 5 years. Patients with tumour disease in situ who are successfully treated only by local resection can be included in the study (including non-melanoma skin cancer in situ); (10) Autoimmune diseases; (11) Persistent arrhythmias requiring anticoagulation therapy (i.e., atrial fibrillation). In this category, isolated ventricular\u002Fsupraventricular presystoles; (12) Use of NSAIDs or other antiplatelet drugs in the past 30 days; (13) cirrhosis of any etiology; (14) use of anticoagulants; (15) Life expectancy less than 1 year; (16) Known aspirin allergy; (17) Known pregnancy; and (18) Severe mental illness.","70 Years",{"count":210,"type":21},355,[25,53],"This is a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of low-dose aspirin (50 mg\u002Fday) in renal and cardiac function protection in people with diabetic nephropathy.",[28],"2023-09-28",{"date":216,"type":33},"2023-10-05",{"date":218,"type":21},"2024-01-01",{"date":220,"type":21},"2027-06-30",{"name":222,"class":40},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":41},"100507555","multidimensional-accurate-diagnosis-and-treatment-technology-and-clinical-transformation-of-type-2-diabetes-nephropathy-100507555","NCT05888909","Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy","Inclusion Criteria:\n\nAge ≥ 18 years old, regardless of gender; Type 2 diabetes; Having a complete medical history and clinical data; If the patients with type 2 diabetes combined with CKD underwent renal biopsy, the pathological diagnosis should be clear; Patients voluntarily signs an informed consent form.\n\nExclusion criteria:\n\nIncomplete medical history or clinical data; Patients with hereditary kidney disease; Combined urinary tract infection; Merge autoimmune system diseases; Patients with malignant tumor were expected to survive less than 6 months; Pregnancy and lactation.",{"count":230,"type":21},2000,"Diabetes nephropathy (DN) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. There is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. Therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging\u002Ftyping, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional Chinese and western medicine.",[28,233,234],"Diabetic Kidney Disease","Type 2 Diabetes",[28,233,234,236,237],"Diagnosis","Treatment","2023-05-25",{"date":240,"type":33},"2023-06-05",{"date":242,"type":33},"2022-08-01",{"date":90,"type":21},{"name":245,"class":40},"Chinese PLA General Hospital",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":252,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":253,"targetDuration":255,"studyType":135,"phases":4,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":41},"100434008","screening-and-application-research-of-early-diabetic-nephropathy-markers-based-on-lipidomics-100434008","NCT04931537","Screening and Application Research of Early Diabetic Nephropathy Markers Based on Lipidomics.","Inclusion Criteria:\n\n1. Subjects who have signed informed consent.\n2. Subjects were 20-80 years old and of either gender.\n3. Subjects showed good compliance, and the follow-up data was available for \\>5 years.\n\nExclusion Criteria:\n\n1. Meet the 1999 World Health Organization (WHO) diagnostic criteria for T1DM、T2DM;\n2. Renal diseases caused by other causes, including primary and secondary;\n3. All kinds of acute infections;\n4. The expected life expectancy (life expectancy or related diseases) was less than 5 years according to the researcher's judgment.\n5. Drug users or drug abusers;\n6. Sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis are in an active period;\n7. Any situation judged by the researcher that affects enrollment.",true,{"count":254,"type":21},1000,"5 Years","Diabetic nephropathy (DN) is one of the major microvascular complications associated with diabetic patients, and also the major global cause of chronic kidney disease and end-stage renal disease (ESRD). Albuminuria and estimated glomerular filtration rate (eGFR) are currently recognized clinical indicators for early diagnosis of DN, however, the sensitivity and specificity are unsatisfactory. The early identification and treatment of DKD are conducive to lowering the risk of kidney damage by as much as 50%. Therefore, it is particularly critical to find new biomarkers to reflect the potential DKD lesions in the clinical silent period earlier and more accurately. Therefore, this study intends to analyze the differentially expressed lipids in early DKD, T2DM and healthy adults by mass spectrometry, and verify the related results by larger samples, so as to screen out early markers of DKD and achieve the ultimate goal of clinical application.",[28,258],"Biomarker",[28,260],"Metabonomics","2021-07-14",{"date":263,"type":33},"2021-07-20",{"date":265,"type":33},"2021-05-01",{"date":267,"type":21},"2028-12-31",{"name":222,"class":40}]