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Eplerenone in HIV Associated Abdominal Fat Accumulation

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital Identifier:
First received: July 27, 2011
Last updated: November 15, 2016
Last verified: November 2016
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
Drug: Eplerenone and lifestyle
Other: placebo and lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Insulin stimulated glucose uptake [ Time Frame: 6 months ]
    Insulin stimulated glucose uptake measured during euglycemic hyperinsulinemic clamp procedure

Secondary Outcome Measures:
  • visceral adipose tissue [ Time Frame: 6 months ]
    visceral adipose tissue area as measured by single-slice computed tomography scan of the abdomen

  • liver fat [ Time Frame: 6 months ]
    hepatic (liver) fat as measured by magnetic resonance spectroscopy

  • intramyocellular lipid [ Time Frame: 6 months ]
    intramyocellular lipid of calf muscles as measured by magnetic resonance spectroscopy

  • flow mediated vasodilation [ Time Frame: 6 months ]
  • potassium [ Time Frame: 6 months ]
    serum measurements of potassium

  • 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 [ Time Frame: 6 months ]
  • markers of immune activation [ Time Frame: 6 months ]

Enrollment: 46
Study Start Date: January 2012
Estimated Primary Completion Date: September 2017 (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 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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)
  2. HIV positive for 5y and on a stable ART regimen for at least 12 months
  3. Age ≥ 30 and ≤ 65 years of age

Exclusion Criteria:

  1. ACE Inhibitor, ARB, verapamil, or spironolactone
  2. Potassium supplementation
  3. Estimated GFR<60, creatinine > 1.5 mg/dL
  4. Serum K > 5.5 mEq/L, ALT > 2.5 times the upper limit of normal, Hgb < 11g/dL
  5. Uncontrolled hypertension (SBP ≥ 160 or DBP ≥ 100)
  6. Current or prior steroid use within past 6 months
  7. Known history of diabetes mellitus or current use of anti-diabetic medications
  8. Concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong inhibitors of CYP34A
  9. Use of St. John's Wart (CYP3A4 inducer)
  10. Pregnant or actively seeking pregnancy, breastfeeding
  11. 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.
  12. Estrogen or progestational derivative use within 3 months
  13. Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for < 3 months.
  14. Current growth hormone or growth hormone releasing hormone use
  15. Current viral, bacterial or other infections (excluding HIV)
  16. Current active substance abuse
  17. Patients with a significant history of cardiovascular disease, including prior MI or stroke
  Contacts and Locations
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Please refer to this study by its identifier: NCT01405456

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
  More Information

Responsible Party: Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01405456     History of Changes
Other Study ID Numbers: 2010P002095
Study First Received: July 27, 2011
Last Updated: November 15, 2016

Keywords provided by Massachusetts General Hospital:
visceral fat

Additional relevant MeSH terms:
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on April 28, 2017