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Trial record 24 of 114 for:    EPLERENONE

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.
 
ClinicalTrials.gov Identifier: NCT01405456
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : May 16, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE July 27, 2011
First Posted Date  ICMJE July 29, 2011
Results First Submitted Date  ICMJE April 16, 2018
Results First Posted Date  ICMJE May 16, 2018
Last Update Posted Date June 15, 2018
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
Insulin Stimulated Glucose Uptake [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
Insulin Stimulated Glucose Uptake [ Time Frame: 6 months ]
Insulin stimulated glucose uptake measured during euglycemic hyperinsulinemic clamp procedure
Change History Complete list of historical versions of study NCT01405456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • 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 [ Time Frame: 6 months ]
    IL-6
  • Markers of Immune Activation [ Time Frame: 6 months ]
    MCP-1
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eplerenone in HIV Associated Abdominal Fat Accumulation
Official Title  ICMJE Randomized Placebo-controlled Trial to Investigate the Effects of Eplerenone in Patients With HIV-associated Abdominal Fat Accumulation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE
  • Drug: Eplerenone and lifestyle
    eplerenone 50mg by mouth daily as well as lifestyle counseling
  • Other: placebo and lifestyle
    placebo pill daily and lifestyle counseling
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Eplerenone and lifestyle
  • 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
    Intervention: Other: placebo and lifestyle
Publications * Srinivasa S, Fitch KV, Wong K, O'Malley TK, Maehler P, Branch KL, Looby SE, Burdo TH, Martinez-Salazar EL, Torriani M, Lyons SH, Weiss J, Feldpausch M, Stanley TL, Adler GK, Grinspoon SK. Randomized, Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Metabolic and Inflammatory Indices in HIV. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2376-2384. doi: 10.1210/jc.2018-00330.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2016)
46
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2011)
66
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01405456
Other Study ID Numbers  ICMJE 2010P002095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven K. Grinspoon, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP