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Clinical Trial Details

Trial ID: L4337
Source ID: NCT02809963
Associated Drug: Eplerenone
Title: Mineralocorticoid Receptor Antagonists in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Type 2
Interventions: DRUG: Eplerenone|DRUG: Placebo
Outcome Measures: Primary: Liver fat content, changes in liver fat content by proton MR spectroscopy, 26 weeks | Secondary: Fat mass distribution, Changes in body fat distribution (total body fat, visceral fat, subcutaneous fat), 26 weeks|insulin resistance, Changes in insulin resistance by HOMA and Matsuda index, 26 weeks|Urinary albumin/creatinine ratio, changes in Urinary albumin/creatinine ratio, 26 weeks|Biomarkers of adipocyte function, Changes in biomarkers of adipocyte function (adiponectin, leptin, FGF-21, TNF-alfa, FFA, IL-6, MCP-1, MAC-1), 26 weeks|24 Hour blood pressure, changes in 24 Hour blood pressure, 26 weeks|Global longitudinal strain (GLS), changes in global longitudinal strain by echocardiography, 26 weeks|systolic and diastolic function og left ventricule, changes in systolic and diastolic function of left ventricule by echocardiography, 26 weeks|Regional and global fibrosis by cardiac magnetic resonance, changes in regional and global fibrosis using Late gadolineum enhancement cardiac magnetic resonance, 26 weeks|biomarkers of myocardial stress and fibrosis, changes in biomarkers of myocardial stress and fibrosis (NT-proBNP, MR-proANP, galectin-3, GDF-15, MR-proADM), 26 weeks|pulse wave analysis, changes in pulse wave analysis, 26 weeks|Quality of life, changes in quality of life using WHO-5, 26 weeks|Diabetes related changes in quality of life, changes in quality of life using W-BQ12, 26 weeks|kidney function, changes in creatinine and eGFR, 26 weeks|potassium, changes in potassium, 26 weeks
Sponsor/Collaborators: Sponsor: Herlev Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 140
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-11
Completion Date: 2017-11
Results First Posted:
Last Update Posted: 2018-06-01
Locations: Herlev and Gentofte Hospital, Department of Endocrinology and Metabolism, Department of internal medicine,, Herlev, 2730, Denmark
URL: https://clinicaltrials.gov/show/NCT02809963

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D200 Eplerenone small molecule DB00700 Details