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Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity; Insulin Resistance

Intervention: Spironolactone (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Brigham and Women's Hospital


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.

Clinical Details

Official title: Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Brachial artery vascular reactivity

Secondary outcome:

Renal plasma flow

Inflammatory markers

Insulin resistance


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria: 1. Age 18-70 years 2. Good health as evidenced by history and physical exam 3. BMI: >30 kg/m2 and <45 kg/m2 Exclusion criteria: 1. Medical illnesses other than treated hypothyroidism 2. BP >135/85 or systolic BP <90 mm Hg 3. Hepatic disease (transaminase > 3 times normal) 4. Renal impairment (Creatinine clearance <60 ml/min) 5. Baseline serum K >5. 0 mmol/L 6. History of drug or alcohol abuse 7. Allergies to spironolactone 8. Participation in any other concurrent clinical trial 9. Women using oral contraceptives within the last 3 months

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Additional Information

Starting date: February 2009
Last updated: August 12, 2013

Page last updated: August 23, 2015

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