NCT00865124

Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Aldosterone is a significant mediator of cardiovascular injury associated with heart failure and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those of angiotensin converting enzyme inhibitors or angiotensin II (ANGII) receptor blockers. This study will test the hypothesis that mineralocorticoid receptor (MR) antagonists exert beneficial cardiovascular effects, specifically by decreasing vascular injury and improving vascular function. A randomized, double-blind study will be conducted, in which participants with Type 2 Diabetes Mellitus will undergo a series of assessments to test heart, blood vessel, and kidney function at baseline, and after 2 and 6 months of treatment with one of the following drugs: 1. spironolactone 2. hydrochlorothiazide (HCTZ) plus potassium 3. placebo In the event of insufficient funds, randomization to the placebo arm will be stopped and primary assessment of outcomes will occur at baseline and after 6 months of treatment.

Conditions

• Type 2 Diabetes Mellitus
• Vascular Disease

Interventions

Type	Name	Description
DRUG	Spironolactone	25 mg capsule daily for 6 months
DRUG	Hydrochlorothiazide + potassium	hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
OTHER	Placebo	Placebo capsule daily

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-08-01
• Completion: 2014-05-01
• First posted: 2009-03-19
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States