Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
The purpose of this study is to find out if spironolactone, a drug that blocks the action of aldosterone, can make the blood vessels work better in people with obesity. The investigators also want to find out whether spironolactone causes changes in levels of insulin and markers of inflammation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications|
- Brachial artery vascular reactivity [ Time Frame: 6 weeks after respective treatments ] [ Designated as safety issue: No ]Change in brachial artery vasodilatation in response to ischemia will be compared between treatment and placebo groups.
- Renal plasma flow [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Change in renal plasma blood flow from baseline will be compared between the treatment and placebo groups.
- Inflammatory markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]TNF alpha and MCP-1 will be measured as markers of inflammation. Changes in TNF alpha and MCP-1 from baseline will be compared between the treatment and placebo groups.
- Insulin resistance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Change in insulin resistance from baseline will be compared between the treatment and placebo groups.
|Study Start Date:||February 2009|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Spironolactone||
50 mg daily for 6 weeks
|Placebo Comparator: Placebo||
Placebo once daily for 6 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406015
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|