Eplerenone in HIV Associated Abdominal Fat Accumulation (NCT01405456) | Clinical Trial Compass
CompletedNot Applicable
Eplerenone in HIV Associated Abdominal Fat Accumulation
United States46 participantsStarted 2012-01
Plain-language summary
The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. In this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. The investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.
Who can participate
Age range30 Years – 65 Years
SexALL
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Inclusion criteria
✓. Increased waist circumference based on NCEP guidelines (\>102cm in men and \>88cm in women) and impaired glucose tolerance (either IFG \> 100 mg/dL but \< 126 mg/dL or 2hr glucose \> 140 mg/dl but \< 200 mg/dL, or fasting insulin \>12 uIU/mL)
✓. HIV positive for 5y and on a stable ART regimen for at least 12 months
✓. Age ≥ 30 and ≤ 65 years of age
Exclusion criteria
✕. ACE Inhibitor, ARB, verapamil, or spironolactone
✕. Potassium supplementation
✕. Estimated GFR\<60, creatinine \> 1.5 mg/dL
✕. Serum K \> 5.5 mEq/L, ALT \> 2.5 times the upper limit of normal, Hgb \< 11g/dL
✕. Uncontrolled hypertension (SBP ≥ 160 or DBP ≥ 100)
✕. Current or prior steroid use within past 6 months
✕. Known history of diabetes mellitus or current use of anti-diabetic medications