Eplerenone in HIV Associated Abdominal Fat Accumulation
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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.
Condition | Intervention |
---|---|
HIV |
Drug: Eplerenone and lifestyle Other: placebo and lifestyle |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | Randomized Placebo-controlled Trial to Investigate the Effects of Eplerenone in Patients With HIV-associated Abdominal Fat Accumulation |
- Insulin stimulated glucose uptake [ Time Frame: 6 months ] [ Designated as safety issue: No ]Insulin stimulated glucose uptake measured during euglycemic hyperinsulinemic clamp procedure
- visceral adipose tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]visceral adipose tissue area as measured by single-slice computed tomography scan of the abdomen
- liver fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]hepatic (liver) fat as measured by magnetic resonance spectroscopy
- intramyocellular lipid [ Time Frame: 6 months ] [ Designated as safety issue: No ]intramyocellular lipid of calf muscles as measured by magnetic resonance spectroscopy
- flow mediated vasodilation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- potassium [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]serum measurements of potassium
- hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- c-reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- plasminogen activator inhibitor 1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- adiponectin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: | 66 |
Study Start Date: | January 2012 |
Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Eplerenone and Lifestyle
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
|
Drug: Eplerenone and lifestyle
eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo Comparator: Placebo and Lifestyle
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
|
Other: placebo and lifestyle
placebo pill daily and lifestyle counseling
|
Detailed Description:
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.
Ages Eligible for Study: | 30 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 ≤ 55 years of age
- Stable CD4 count and HIV viral load in the past year
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
- 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
Contact: Katie Fitch, NP | 617-724-8015 | kfitch@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven Grinspoon, MD | Massachusetts General Hospital |
No publications provided
Responsible Party: | Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01405456 History of Changes |
Other Study ID Numbers: | 2010P002095 |
Study First Received: | July 27, 2011 |
Last Updated: | August 10, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
HIV-infection eplerenone aldosterone visceral fat lipodystrophy |
Additional relevant MeSH terms:
Eplerenone Spironolactone Aldosterone Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Diuretics Natriuretic Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 07, 2013