Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Spironolactone

Group Type ACTIVE_COMPARATOR

Spironolactone

Intervention Type DRUG

50 mg once daily for 6 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo-matching spironolactone once daily for 6 weeks.

Interventions

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Spironolactone

50 mg once daily for 6 weeks.

Intervention Type DRUG

Placebo

Placebo-matching spironolactone once daily for 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No