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
Summary
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 flowInflammatory markers Insulin resistance
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
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