N/A N=46 Randomized Quadruple-blind Treatment

Eplerenone in HIV Associated Abdominal Fat Accumulation

HIV

Bottom Line

View on ClinicalTrials.gov: NCT01405456 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Insulin Stimulated Glucose Uptake — 7.70; 8.58 mg/min per μIU/ml — p=0.71

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Eplerenone and lifestyle (Drug); placebo and lifestyle (Other)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin Stimulated Glucose Uptake	7.70; 8.58	0.71
SECONDARY Visceral Adipose Tissue	231; 233	0.42
SECONDARY Liver Fat	6; 4	0.51
SECONDARY Intramyocellular Lipid	0.4; 0.4	0.04 sig
SECONDARY Flow Mediated Vasodilation	15.3; 9.6	0.44
SECONDARY Potassium	4.2; 4.2	0.07
SECONDARY Hemoglobin A1c	5.7; 5.8	0.70
SECONDARY C-Reactive Protein	2.8; 2.8	0.10
SECONDARY Plasminogen Activator Inhibitor 1	35; 35	0.37
SECONDARY Adiponectin	4015; 4014	0.78
SECONDARY Markers of Systemic Inflammation	9.8; 8.9	0.10
SECONDARY Markers of Immune Activation	205; 210	0.04 sig

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.

Eligibility Criteria

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 140 mg/dl but 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 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
Concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong inhibitors of CYP34A
Use of St. John's Wart (CYP3A4 inducer)
Pregnant or actively seeking pregnancy, breastfeeding
For women: Pregnant or actively seeking pregnancy, breastfeeding, failure to use an acceptable non-hormonal form of birth control, including abstinence, barrier contraceptives, or non-hormonal IUD.
Estrogen or progestational derivative use within 3 months
Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for < 3 months.
Current growth hormone or growth hormone releasing hormone use
Current viral, bacterial or other infections (excluding HIV)
Current active substance abuse
Patients with a significant history of cardiovascular disease, including prior MI or stroke

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01405456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.