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Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00865124
First received: March 17, 2009
Last updated: May 19, 2017
Last verified: May 2017
Results First Received: April 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes Mellitus
Vascular Disease
Interventions: Drug: Spironolactone
Drug: Hydrochlorothiazide + potassium
Other: 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
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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
Spironolactone (MR Blockade) 25 mg capsule daily for 6 months
Hydrochlorothiazide + Potassium Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
Placebo Placebo capsule daily

Participant Flow:   Overall Study
    Spironolactone (MR Blockade)   Hydrochlorothiazide + Potassium   Placebo
STARTED   27   25   17 
COMPLETED   23   24   17 
NOT COMPLETED   4   1   0 
Physician Decision                2                1                0 
Withdrawn consent                2                0                0 



  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.
All participants who completed the study.

Reporting Groups
  Description
Spironolactone (MR Blockade) Spironolactone: 25 mg capsule daily for 6 months
Hydrochlorothiazide + Potassium Hydrochlorothiazide + potassium: hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
Placebo Capsule Placebo: Placebo capsule daily
Total Total of all reporting groups

Baseline Measures
   Spironolactone (MR Blockade)   Hydrochlorothiazide + Potassium   Placebo Capsule   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   24   17   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (6)   53  (7)   55  (10)   54.72  (7.66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  26.1%      11  45.8%      7  41.2%      24  37.5% 
Male      17  73.9%      13  54.2%      10  58.8%      40  62.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Coronary Flow Reserve From Baseline to 6 Months   [ Time Frame: Baseline and six months ]

2.  Secondary:   Change in Mitral Annulus Velocities on Tissue Doppler (Delta E/e’ Ratio), a Measure of Diastolic Function   [ Time Frame: Baseline and six months ]

3.  Secondary:   Mitral Annulus Velocities on Tissue Doppler (Delta E/e’ Ratio), a Measure of Diastolic Function (With Angiotensin II)   [ Time Frame: Baseline and six months ]

4.  Secondary:   Change in Renal Plasma Flow   [ Time Frame: Baseline and six months ]


  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: Gail K. Adler
Organization: Brigham and Women’s Hospital
phone: 617-732-5661
e-mail: gadler@partners.org


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

Responsible Party: Gail Kurr Adler, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00865124     History of Changes
Other Study ID Numbers: 2007-P-000564
1R01HL087060-01A2 ( U.S. NIH Grant/Contract )
Study First Received: March 17, 2009
Results First Received: April 12, 2017
Last Updated: May 19, 2017