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Eplerenone in HIV Associated Abdominal Fat Accumulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405456
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : May 16, 2018
Last Update Posted : June 15, 2018
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Drug: Eplerenone and lifestyle Other: placebo and lifestyle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : January 2012
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Eplerenone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Insulin Stimulated Glucose Uptake [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Visceral Adipose Tissue [ Time Frame: 6 months ]
  2. Liver Fat [ Time Frame: 6 months ]
  3. Intramyocellular Lipid [ Time Frame: 6 months ]
  4. Flow Mediated Vasodilation [ Time Frame: 6 months ]
  5. Potassium [ Time Frame: 6 months ]
  6. Hemoglobin A1c [ Time Frame: 6 months ]
  7. C-Reactive Protein [ Time Frame: 6 months ]
  8. Plasminogen Activator Inhibitor 1 [ Time Frame: 6 months ]
  9. Adiponectin [ Time Frame: 6 months ]
  10. Markers of Systemic Inflammation [ Time Frame: 6 months ]

  11. Markers of Immune Activation [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405456

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01405456     History of Changes
Other Study ID Numbers: 2010P002095
First Posted: July 29, 2011    Key Record Dates
Results First Posted: May 16, 2018
Last Update Posted: June 15, 2018
Last Verified: May 2018
Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
visceral fat
Additional relevant MeSH terms:
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Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents