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Eplerenone in HIV Associated Abdominal Fat Accumulation

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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: Eplerenone and lifestyle
Other: placebo and lifestyle

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling

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

placebo and lifestyle: placebo pill daily and lifestyle counseling


Participant Flow:   Overall Study
    Eplerenone and Lifestyle   Placebo and Lifestyle
STARTED   25   21 
COMPLETED   22   20 
NOT COMPLETED   3   1 
Lost to Follow-up                2                1 
Physician Decision                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling

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

placebo and lifestyle: placebo pill daily and lifestyle counseling

Total Total of all reporting groups

Baseline Measures
   Eplerenone and Lifestyle   Placebo and Lifestyle   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   21   46 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   25   21   46 
   49  (6)   52  (6)   51  (6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   25   21   46 
Female      10  40.0%      6  28.6%      16  34.8% 
Male      15  60.0%      15  71.4%      30  65.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   25   21   46 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      9  36.0%      11  52.4%      20  43.5% 
White      15  60.0%      9  42.9%      24  52.2% 
More than one race      1   4.0%      0   0.0%      1   2.2% 
Unknown or Not Reported      0   0.0%      1   4.8%      1   2.2% 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed   25   21   46 
United States   25   21   46 
Insulin Stimulated Glucose Uptake [1] 
[Units: Mg/min per μIU/ml]
Median (Inter-Quartile Range)
     
Participants Analyzed   24   21   45 
   7.26 
 (5.74 to 9.55) 
 7.52 
 (5.12 to 10.43) 
 7.44 
 (5.64 to 9.87) 
[1] Endpoint could not be obtained
Visceral Adipose Tissue [1] 
[Units: Cm2]
Median (Inter-Quartile Range)
     
Participants Analyzed   23   21   44 
   215 
 (154 to 324) 
 241 
 (147 to 295) 
 230 
 (154 to 308) 
[1] Endpoint could not be obtained
Liver Fat [1] 
[Units: Percentage of intrahepatic lipid]
Median (Inter-Quartile Range)
     
Participants Analyzed   22   21   43 
   5 
 (3 to 12) 
 5 
 (2 to 12) 
 5 
 (3 to 12) 
[1] Endpoint could not be obtained
Intramyocellular Lipid [1] 
[Units: Percentage of intramyocellular lipid]
Median (Inter-Quartile Range)
     
Participants Analyzed   24   21   45 
   0.5 
 (0.2 to 0.6) 
 0.3 
 (0.2 to 0.5) 
 0.4 
 (0.2 to 0.5) 
[1] Endpoint could not be obtained
Flow Mediated Vasodilation [1] 
[Units: Percentage of maximum change]
Median (Inter-Quartile Range)
     
Participants Analyzed   24   19   43 
   13.0 
 (9.7 to 19.3) 
 13.4 
 (10.8 to 17.6) 
 13.0 
 (10.7 to 17.6) 
[1] Endpoint could not be obtained
Potassium 
[Units: mEq/L]
Mean (Standard Deviation)
     
Participants Analyzed   25   21   46 
   4.1  (0.2)   4.0  (0.2)   4.1  (0.2) 
Hemoglobin A1c 
[Units: Percentage]
Median (Inter-Quartile Range)
     
Participants Analyzed   25   21   46 
   5.7 
 (5.5 to 6.0) 
 5.8 
 (5.3 to 6.1) 
 5.7 
 (5.5 to 6.0) 
C-reactive Protein [1] 
[Units: mg/L]
Median (Inter-Quartile Range)
     
Participants Analyzed   24   21   45 
   3.3 
 (1.2 to 9.4) 
 3.7 
 (1.6 to 9.8) 
 3.4 
 (1.3 to 9.6) 
[1] Endpoint could not be evaluated
Plasminogen Activator Inhibitor 1 [1] 
[Units: ng/mL]
Mean (Standard Deviation)
     
Participants Analyzed   24   21   45 
   36.7  (18.3)   37.0  (18.7)   36.9  (18.3) 
[1] Endpoint could not be obtained
Adiponectin [1] 
[Units: pg/mL]
Median (Inter-Quartile Range)
     
Participants Analyzed   24   21   45 
   4016 
 (3439 to 5360) 
 4673 
 (3302 to 6042) 
 4527 
 (3373 to 5484) 
[1] Endpoint could not be evaluated
Markers of Systemic Inflammation [1] [2] 
[Units: pg/mL]
Median (Inter-Quartile Range)
     
Participants Analyzed   24   21   45 
   10.2 
 (5.2 to 19.8) 
 7.9 
 (6.1 to 18.3) 
 9.1 
 (5.9 to 19.3) 
[1] IL-6
[2] Endpoint could not be evaluated
Markers of Immune Activation [1] [2] 
[Units: pg/mL]
Mean (Standard Deviation)
     
Participants Analyzed   24   21   45 
   205  (78)   191  (51)   198  (66) 
[1] MCP-1
[2] Endpoint could not be evaluated


  Outcome Measures

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

2.  Secondary:   Visceral Adipose Tissue   [ Time Frame: 6 months ]

3.  Secondary:   Liver Fat   [ Time Frame: 6 months ]

4.  Secondary:   Intramyocellular Lipid   [ Time Frame: 6 months ]

5.  Secondary:   Flow Mediated Vasodilation   [ Time Frame: 6 months ]

6.  Secondary:   Potassium   [ Time Frame: 6 months ]

7.  Secondary:   Hemoglobin A1c   [ Time Frame: 6 months ]

8.  Secondary:   C-Reactive Protein   [ Time Frame: 6 months ]

9.  Secondary:   Plasminogen Activator Inhibitor 1   [ Time Frame: 6 months ]

10.  Secondary:   Change in Adiponectin   [ Time Frame: 6 months ]

11.  Secondary:   Markers of Systemic Inflammation   [ Time Frame: 6 months ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven K. Grinspoon
Organization: Massachusetts General Hospital
phone: 6177249109
e-mail: sgrinspoon@mgh.harvard.edu



Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01405456     History of Changes
Other Study ID Numbers: 2010P002095
First Submitted: July 27, 2011
First Posted: July 29, 2011
Results First Submitted: April 16, 2018
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018