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Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rajesh K. Garg, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01406015
First received: July 26, 2011
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: January 29, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Prevention
Conditions: Obesity
Insulin Resistance
Interventions: Drug: Spironolactone
Drug: Placebo

  Participant Flow
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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
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Reporting Groups
  Description
Spironolactone Spironolactone 50 mg once daily for 6 weeks.
Placebo Placebo-matching spironolactone once daily for 6 weeks.

Participant Flow:   Overall Study
    Spironolactone   Placebo
STARTED   19   19 
COMPLETED   16   16 
NOT COMPLETED   3   3 
Withdrawal by Subject                3                3 



  Baseline Characteristics
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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.
Baseline characteristics are based on the total number of participants who completed the study.

Reporting Groups
  Description
Spironolactone Spironolactone 50 mg once daily for 6 weeks.
Placebo Placebo-matching spironolactone once daily for 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Spironolactone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (11.6)   40  (12.3)   43.4  (12.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  62.5%      12  75.0%      22  68.8% 
Male      6  37.5%      4  25.0%      10  31.3% 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 38  (6.6)   36  (4.6)   36.8  (5.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Post-ischemic Dilatation   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:   Change From Baseline in Para-aminohippurate (PAH) Clearance   [ Time Frame: Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion) ]

3.  Secondary:   Change From Baseline in Markers of Inflammation   [ Time Frame: Baseline and Week 6 ]

4.  Secondary:   Change From Baseline in Insulin Sensitivity Index (ISI)   [ Time Frame: Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes) ]

5.  Secondary:   Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rajesh K. Garg
Organization: Brigham and Women's Hospital
e-mail: RGARG@bwh.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rajesh K. Garg, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01406015     History of Changes
Other Study ID Numbers: 2009P-000311
Study First Received: July 26, 2011
Results First Received: January 29, 2017
Last Updated: March 20, 2017