Diabetes Type 2 Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study of the Effect of Mineralocorticoid Receptor Antagonists in Type 2 Diabetes Patients on Myocardial Function, Glucose and Fat Metabolism (The MIRAD-study)
Verified date | May 2018 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the effect of selective blocking of the mineralocorticoid receptor in patients with type 2 diabetes on insulin resistance, lipid metabolism and myocardial function.
Status | Completed |
Enrollment | 140 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Able to understand the written patient information and to give informed consent - Type 2 diabetes mellitus (WHO criteria), diagnosed at least 3 months prior to baseline - Blood pressure treatment according to standard guidelines - Negative pregnancy test (fertile women) - Be willing to change/pause potassium sparing medication - Age 18-85 years - Patients must have high cardiovascular risk factors, defined as one of the following: NT-proBNP = 70 pg/ml (taken within the last 6 months prior to baseline) Albuminuria ( albumin/creatinine ratio = 30 mg/g Confirmed history of myocardial infarction (= 3 months prior to baseline) Or patient discharged from hospital with a documented diagnosis of unstable angina within 24 months prior to baseline Evidence of coronary artery disease by CAG in 1 or more major coronary arteries OR at least one of the following: a positive noninvasive stress test, OR a positive stress echocardiography showing regional systolic wall motion abnormalities, OR a positive scintigraphy test showing stress-induced ischemia History of ischemic or hemorrhagic stroke (= 3 months prior to informed consent) Presence of peripheral artery disease (symptomatic or not ) documented by either: previous limb angioplasty, stenting or bypass surgery; or previous limb or foot amputation due to circulatory insufficiency; or angiographic evidence of significant (= 50%) peripheral artery stenosis in at least one limb; or evidence from a non-invasive measurement of significant (=50% or as reported as hemodynamically significant) peripheral artery stenosis in at least one limb; or ankle brachial index of = 0.9 Left ventricle hypertrophy: Documented at echocardiography ECG: R-spike in V5/V6 = 25 mm or S-spike in V1 + R-spike in V5/V6 = 35 mm Patients both with and without a cardiovascular risk factor can be randomized to the fat biopsy sub study. Exclusion Criteria: - Allergic to the study medication - Systolic HF (LVEF = 40%) - Impaired kidney function, eGFR = 40 ml/min - Severe liver insufficiency (Child-Pugh class C) - Treatment with MR antagonist within 3 months prior to baseline - Treatment with both ACE inhibitors and Angiotensin II Receptor blockers. - Serum-potassium = 5.0 mmol/l - Serum-sodium = 135 mmol/l - Myocardial infarction, unstable angina pectoris or bypass graft surgery within 3 months prior to baseline - Persistant atrial fibrillation (except for the fat biopsy sub population) - ECG showing malign ventricular arrhythmia or prolonged QT-interval (> 500ms) - Untreated heart valve disease - ICD-unit/pacemaker - Pregnancy or desire hereof or breastfeeding - Women in the fertile age not using safe contraceptives (spiral, hormonal contraceptives) - Cancer unless complete remission = 5 year - Alcohol-/drug-abuse - Inflammatory bowel disease - Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable to participate in the study - Simultaneous participation in another clinical study - Treatment with CYP3A4-inhibitors (e.g. itraconazol, etoconazol, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodon) |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev and Gentofte Hospital, Department of Endocrinology and Metabolism, Department of internal medicine, | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | insulin resistance | Changes in insulin resistance by HOMA and Matsuda index | 26 weeks | |
Secondary | Urinary albumin/creatinine ratio | changes in Urinary albumin/creatinine ratio | 26 weeks | |
Secondary | 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 | |
Secondary | 24 Hour blood pressure | changes in 24 Hour blood pressure | 26 weeks | |
Secondary | Global longitudinal strain (GLS) | changes in global longitudinal strain by echocardiography | 26 weeks | |
Secondary | systolic and diastolic function og left ventricule | changes in systolic and diastolic function of left ventricule by echocardiography | 26 weeks | |
Secondary | Regional and global fibrosis by cardiac magnetic resonance | changes in regional and global fibrosis using Late gadolineum enhancement cardiac magnetic resonance | 26 weeks | |
Secondary | 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 | |
Secondary | pulse wave analysis | changes in pulse wave analysis | 26 weeks | |
Secondary | Quality of life | changes in quality of life using WHO-5 | 26 weeks | |
Secondary | Diabetes related changes in quality of life | changes in quality of life using W-BQ12 | 26 weeks | |
Secondary | kidney function | changes in creatinine and eGFR | 26 weeks | |
Secondary | potassium | changes in potassium | 26 weeks |
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