Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Mass General Brigham

Status: Completed

Conditions: Insulin Resistance; Obesity

Treatments: Drug: Placebo; Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT01406015

2009P-000311

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-70 years
2. Good health as evidenced by history and physical exam
3. Body Mass Index (BMI): >30 kg/m2 and <45 kg/m2

Exclusion criteria

1. Medical illnesses other than treated hypothyroidism
2. Blood Pressure (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 Potassium (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Spironolactone

Active Comparator group

Treatment:

Drug: Spironolactone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo