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Trial record 24 of 112 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

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
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 25 21
Completed 22 20
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             2             1
Physician Decision             1             0
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 25 21 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 21 participants 46 participants
49  (6) 52  (6) 51  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 46 participants
Female
10
  40.0%
6
  28.6%
16
  34.8%
Male
15
  60.0%
15
  71.4%
30
  65.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 46 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 21 participants 46 participants
25
 100.0%
21
 100.0%
46
 100.0%
Insulin Stimulated Glucose Uptake   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Mg/min per μIU/ml
Number Analyzed 24 participants 21 participants 45 participants
7.26
(5.74 to 9.55)
7.52
(5.12 to 10.43)
7.44
(5.64 to 9.87)
[1]
Measure Description: Insulin stimulated glucose uptake at steady state using the euglycemic hyperinsulinemic clamp technique normalized to insulin and lean body mass.
[2]
Measure Analysis Population Description: Endpoint could not be obtained. Subject was unable to complete the procedure.
Visceral Adipose Tissue   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Cm^2
Number Analyzed 23 participants 21 participants 44 participants
215
(154 to 324)
241
(147 to 295)
230
(154 to 308)
[1]
Measure Description: Abdominal visceral fat obtained by MRI.
[2]
Measure Analysis Population Description: Endpoint could not be obtained. Subjects could could not complete the procedure.
Liver Fat   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Percentage of intrahepatic lipid
Number Analyzed 22 participants 21 participants 43 participants
5
(3 to 12)
5
(2 to 12)
5
(3 to 12)
[1]
Measure Description: Intrahepatic lipid obtained by MRS.
[2]
Measure Analysis Population Description: Endpoint could not be obtained. Subjects could not complete the procedure.
Intramyocellular Lipid   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Percentage of intramyocellular lipid
Number Analyzed 24 participants 21 participants 45 participants
0.5
(0.2 to 0.6)
0.3
(0.2 to 0.5)
0.4
(0.2 to 0.5)
[1]
Measure Description: Intramyocellular lipid of the tibialis anterior muscle obtained by MRS.
[2]
Measure Analysis Population Description: Endpoint could not be obtained. Subjects could not complete the procedure.
Flow Mediated Vasodilation   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Percentage of maximum change
Number Analyzed 24 participants 19 participants 43 participants
13.0
(9.7 to 19.3)
13.4
(10.8 to 17.6)
13.0
(10.7 to 17.6)
[1]
Measure Description: Flow mediated vasodilation obtained at the brachial artery.
[2]
Measure Analysis Population Description: Endpoint could not be obtained. Studies were of poor quality and data could not be analyzed.
Potassium  
Mean (Standard Deviation)
Unit of measure:  mEq/L
Number Analyzed 25 participants 21 participants 46 participants
4.1  (0.2) 4.0  (0.2) 4.1  (0.2)
Hemoglobin A1c  
Median (Inter-Quartile Range)
Unit of measure:  Percentage
Number Analyzed 25 participants 21 participants 46 participants
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] 
Median (Inter-Quartile Range)
Unit of measure:  mg/L
Number Analyzed 24 participants 21 participants 45 participants
3.3
(1.2 to 9.4)
3.7
(1.6 to 9.8)
3.4
(1.3 to 9.6)
[1]
Measure Analysis Population Description: Endpoint could not be evaluated. Sufficient sample was not obtained.
Plasminogen Activator Inhibitor 1   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 24 participants 21 participants 45 participants
36.7  (18.3) 37.0  (18.7) 36.9  (18.3)
[1]
Measure Analysis Population Description: Endpoint could not be obtained. Sufficient sample was not obtained.
Adiponectin   [1] 
Median (Inter-Quartile Range)
Unit of measure:  pg/mL
Number Analyzed 24 participants 21 participants 45 participants
4016
(3439 to 5360)
4673
(3302 to 6042)
4527
(3373 to 5484)
[1]
Measure Analysis Population Description: Endpoint could not be evaluated. Sufficient sample was not obtained.
Markers of Systemic Inflammation   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  pg/mL
Number Analyzed 24 participants 21 participants 45 participants
10.2
(5.2 to 19.8)
7.9
(6.1 to 18.3)
9.1
(5.9 to 19.3)
[1]
Measure Description: IL-6
[2]
Measure Analysis Population Description: Endpoint could not be evaluated. Sufficient sample was not obtained.
Markers of Immune Activation   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 24 participants 21 participants 45 participants
205  (78) 191  (51) 198  (66)
[1]
Measure Description: MCP-1
[2]
Measure Analysis Population Description: Endpoint could not be evaluated. Sufficient sample was not obtained.
1.Primary Outcome
Title Insulin Stimulated Glucose Uptake
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 20
Median (Inter-Quartile Range)
Unit of Measure: mg/min per μIU/ml
7.70
(5.01 to 8.36)
8.58
(5.76 to 12.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Visceral Adipose Tissue
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: cm^2
231
(145 to 327)
233
(142 to 318)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Liver Fat
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 19 18
Median (Inter-Quartile Range)
Unit of Measure: percentage of intrahepatic lipid
6
(3 to 13)
4
(2 to 9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Intramyocellular Lipid
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: percentage of intramyocellular lipid
0.4
(0.2 to 0.6)
0.4
(0.3 to 0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Flow Mediated Vasodilation
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 20 17
Median (Inter-Quartile Range)
Unit of Measure: percentage of maximum change
15.3
(7.7 to 17.3)
9.6
(6.9 to 20.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Potassium
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 22 20
Mean (Standard Error)
Unit of Measure: mEq/L
4.2  (0.1) 4.2  (0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Mean serum measurements of Potassium
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Hemoglobin A1c
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 22 20
Median (Inter-Quartile Range)
Unit of Measure: percentage
5.7
(5.4 to 6.0)
5.8
(5.4 to 5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Hemoglobin A1c from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title C-Reactive Protein
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 18
Median (Inter-Quartile Range)
Unit of Measure: mg/L
2.8
(1.7 to 5.8)
2.8
(0.9 to 10.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in C-Reactive Protein from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Plasminogen Activator Inhibitor 1
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: ng/mL
35  (3) 35  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Adiponectin
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 18
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
4015
(2926 to 5588)
4014
(3213 to 6012)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in Adiponectin from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Markers of Systemic Inflammation
Hide Description IL-6
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 17
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
9.8
(4.8 to 16.6)
8.9
(6.3 to 27.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in IL-6 from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Markers of Immune Activation
Hide Description MCP-1
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: pg/mL
205  (19) 210  (17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone and Lifestyle, Placebo and Lifestyle
Comments Change in MCP-1 from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eplerenone and Lifestyle Placebo and Lifestyle
Hide Arm/Group Description

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

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

All-Cause Mortality
Eplerenone and Lifestyle Placebo and Lifestyle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone and Lifestyle Placebo and Lifestyle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eplerenone and Lifestyle Placebo and Lifestyle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/25 (52.00%)      11/21 (52.38%)    
Cardiac disorders     
Dizziness *  1/25 (4.00%)  1 1/21 (4.76%)  1
Hypertension *  0/25 (0.00%)  0 2/21 (9.52%)  2
Gastrointestinal disorders     
Abdominal Pain *  1/25 (4.00%)  1 0/21 (0.00%)  0
Nausea *  1/25 (4.00%)  1 0/21 (0.00%)  0
Diarrhea *  2/25 (8.00%)  2 0/21 (0.00%)  0
Anorexia *  1/25 (4.00%)  1 0/21 (0.00%)  0
Rectal Bleed *  2/25 (8.00%)  2 0/21 (0.00%)  0
General disorders     
Headache *  0/25 (0.00%)  0 1/21 (4.76%)  1
Fatigue *  1/25 (4.00%)  1 0/21 (0.00%)  0
Insomnia *  1/25 (4.00%)  1 0/21 (0.00%)  0
Infections and infestations     
Other Infection *  1/25 (4.00%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal Pain *  1/25 (4.00%)  1 2/21 (9.52%)  2
Psychiatric disorders     
Mood Symptoms *  1/25 (4.00%)  1 1/21 (4.76%)  1
Renal and urinary disorders     
Elevated Creatinine *  1/25 (4.00%)  1 1/21 (4.76%)  1
Urinary Symptoms *  1/25 (4.00%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection *  4/25 (16.00%)  4 6/21 (28.57%)  6
Skin and subcutaneous tissue disorders     
Rash *  1/25 (4.00%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Steven K. Grinspoon
Organization: Massachusetts General Hospital
Phone: 6177249109
EMail: sgrinspoon@mgh.harvard.edu
Layout table for additonal information
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: June 15, 2018