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.
The study is 12 months long, with two phases. In the initial, 6-month phase, volunteers are randomly assigned to receive either eplerenone or placebo (an inactive pill). In addition, all volunteers will receive counseling about healthy diet and lifestyle, and will be asked to follow guidelines for a healthy level of physical activity. In the second 6-months of the study, all volunteers will continue to receive lifestyle modification and all will receive eplerenone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
eplerenone 50mg by mouth daily as well as lifestyle counseling
placebo pill daily and lifestyle counseling
Massachusetts General Hospital
Boston, Massachusetts, United States
Insulin Stimulated Glucose Uptake
Time frame: 6 months
Visceral Adipose Tissue
Time frame: 6 months
Liver Fat
Time frame: 6 months
Intramyocellular Lipid
Time frame: 6 months
Flow Mediated Vasodilation
Time frame: 6 months
Potassium
Time frame: 6 months
Hemoglobin A1c
Time frame: 6 months
C-Reactive Protein
Time frame: 6 months
Plasminogen Activator Inhibitor 1
Time frame: 6 months
Adiponectin
Time frame: 6 months
Markers of Systemic Inflammation
IL-6
Time frame: 6 months
Markers of Immune Activation
MCP-1
Time frame: 6 months
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