diabetes (type 2) MedDRA version: 18.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Eplerenone
Pharmaceutical Form: Coated tablet
INN or Proposed INN: eplerenone
Other descriptive name: EPLERENONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Herlev Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 • NT-proBNP = 70 pg/ml5 (taken within the last 6 months prior to baseline) • Stable dose of anti-diabetics within 30 days prior to baseline • Blood pressure treatment according to standard guidelines • Negative pregnancy test (fertile women) • Be willing to change/pause potassium sparing medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
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 • Serum-potassium = 5.0 mmol/l • Serum-sodium 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective to investigate the effect of Eplerenone 200 mg once daily compared to placebo on: • Liver fat content by proton MR spectroscopy;Secondary Objective: Secondary objectives to investigate the effect of Eplerenone on: • Fat mass distribution: total abdominal fat, VAT/subcutaneous and lower body fat • Insulin resistance by HOMA and Matsuda index, glucose homeostasis by HbA1c • Global longitudinal strain (GLS) • Systolic and diastolic function of the left ventricule: LVEF, EDV, ESV, S’, E’ • Regional and global fibrosis, and LV mass by MRI • Biomarkers of myocardial stress and fibrosis: NT-proBNP, MR-proANP, Galectin-3, GDF-15, MR-proADM • Biomarkers of adipocyte function: adiponectin, leptin, TNF-a, FFA, IL-6, MCP-1, MAC-1, FGF-21 • Biomarkers of molecular biology: microRNA profiles, gene, RNA, SNPs-profiles, telomere length in white blood cells • Urinary albumin/creatinine ratio • Pulse-wave velocity and pulse-wave analysis • 24 hour blood pressure • Quality of life (WHO-5, W-BQ12);Primary end point(s): Primary endpoints • Changes in liver fat content by proton MR spectroscopy from baseline to week 26 ;Timepoint(s) of evaluation of this end point: at baseline and efter 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: at baseline and after 26 weeks;Secondary end point(s): Secondary endpoints change from baseline to 26 week in: • Fat mass distribution: total abdominal fat, VAT/subcutaneous and lower body fat • Insulin resistance by HOMA and Matsuda index, glucose homeostasis by HbA1c • Global longitudinal strain (GLS) • Systolic and diastolic function of the left ventricule: LVEF, EDV, ESV, S’, E’ • Regional and global fibrosis, and LV mass by MRI • Biomarkers of myocardial stress and fibrosis: NT-proBNP, MR-proANP, Galectin-3, GDF-15, MR-proADM • Biomarkers of adipocyte function: adiponectin, leptin, TNF-a, FFA, IL-6, MCP-1, MAC-1, FGF-21 • Biomarkers of molecular biology: microRNA profiles, gene, RNA, SNPs-profiles, telomere length in white blood cells • Urinary albumin/creatinine ratio • Pulse-wave velocity and pulse-wave analysis • 24 hour blood pressure • Quality of life (WHO-5, W-BQ12) | — |
Countries
Denmark
Contacts
Public ContactForskingsenheden
Herlev Hospital
Outcome results
None listed