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Clinical Trial Details

Trial ID: L2463
Source ID: NCT02035891
Associated Drug: Colchicine 0.5mg/D
Title: Low-dose Colchicine in Patients With Type 2 Diabetes Mellitus and Microalbuminuria
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetic Nephropathy
Interventions: DRUG: colchicine 0.5mg/d|DRUG: placebo 0.5mg/d
Outcome Measures: Primary: The incidence of overt nephropathy, overt nephropathy is defined as any one of the events described below: (1) UACR greater than 300 mg/g Cr; (2) 24 h urinary albumin greater than 300 mg; (3)doubling of the serum creatinine level to at least 200 μmol per liter; (4)the need for renal-replacement therapy;(5) death due to renal disease., 3 years | Secondary: The proportion of patients achieving at least a 15% reduction in UACR, Renal outcome, 3 years|Changes in estimated Glomerular Filtration Rate (eGFR), Renal outcome, 3 years|The number of patients who have new or worsening diabetic neuropathy, diabetic neuropathy was assessed based on biothesiometer., 3 years|The number of patients who have new or worsening diabetic retinopathy, Diabetic retinopathy was diagnosed according to the six-level grading scale of the European Community- funded Concerted Action Programme into the Epidemiology and Prevention of Diabetes (EURODIAB), 3 years|changes in CIMT from baseline to the 3rd year, cardiovascular outcome, 18 months and 3 year|The number of patients who have new cardiovascular events, cardiovascular events include death from cardiovascular causes, nonfatal stroke, nonfatal myocardial infarction, coronary-artery bypass grafting, percutaneous coronary intervention or revascularization for peripheral atherosclerotic arterial disease, and amputation because of ischemia, 6 years|changes of UACR, evaluated at 6, 12, 18, 24, 36, 48, 60, 72 months, 6 years|changes of eGFR, evaluated at 6, 12, 18, 24, 36, 48, 60, 72 months, 6 years|Death from any cause, All-cause mortality, 6 years
Sponsor/Collaborators: Sponsor: Chongqing Medical University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 160
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-12
Completion Date: 2023-06
Results First Posted:
Last Update Posted: 2019-01-31
Locations: The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China
URL: https://clinicaltrials.gov/show/NCT02035891