Study Results
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Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2003-08-31
2006-03-31
Brief Summary
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1. Coronary microvascular function assessed by MRI perfusion reserve,
2. Endothelial dysfunction assessed by brachial artery reactivity studies, and
3. Inflammation assessed by blood measurements of c-reactive protein (CRP), monocyte chemoattractant protein-1 (MCP-1), and plasminogen activator inhibitor-1 (PAI-1).
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Detailed Description
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Specific aims for this proposal are to determine in patients with type 1 or type 2 diabetes mellitus and proteinuria, already receiving ACE inhibitor or ARB therapy, the effects of an aldosterone receptor antagonist vs. hydrochlorothiazide on:
1. Coronary microvascular function assessed by MRI perfusion reserve,
2. Endothelial dysfunction assessed by brachial artery reactivity studies,
3. Inflammation and cellular oxidative stress and injury, assessed by c-reactive protein (CRP), MCP-1, plasminogen activator inhibitor-1 (PAI-1).
4. Proteinuria and whether there is a differential effect when a MR antagonist or HCTZ is added to the ACE inhibitor therapy.
This is a double-blind, randomized, cross-over study of men and women (21-64 years old) with type 1 or type 2 diabetes mellitus and albuminuria (³30 mg/g creatinine). Participants will be randomized to a MR antagonist + placebo or HCTZ + potassium supplementation for 6 weeks. The MR antagonist arm will receive eplerenone 50 mg daily. The HCTZ arm will receive HCTZ 12.5 mg with potassium 10 Meq daily. Amlodipine 5 to 10 mg daily will be added during run phase to control blood pressure. Blood pressure goal is less than 130/80 mm Hg. There will be a 4-week washout period before the patients are crossed-over to the other study arm. MRI perfusion reserve, brachial artery reactivity, and blood samples will be obtained at the beginning and end of each treatment arm.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
MR antagonist (Eplerenone) + placebo
eplerenone
50 mg daily for 6 weeks with placebo
2
Hydrochlorothiazide plus potassium
Hydrochlorothiazide
HCTZ 12.5 mg with potassium (10 mEq) daily for 6 weeks
Interventions
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eplerenone
50 mg daily for 6 weeks with placebo
Hydrochlorothiazide
HCTZ 12.5 mg with potassium (10 mEq) daily for 6 weeks
Eligibility Criteria
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Inclusion Criteria
21 Years
64 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Brigham and Women's Hospital
Principal Investigators
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Gail K Adler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital Boston, MA
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Joffe HV, Kwong RY, Gerhard-Herman MD, Rice C, Feldman K, Adler GK. Beneficial effects of eplerenone versus hydrochlorothiazide on coronary circulatory function in patients with diabetes mellitus. J Clin Endocrinol Metab. 2007 Jul;92(7):2552-8. doi: 10.1210/jc.2007-0393. Epub 2007 May 8.
Other Identifiers
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2003-P-001273 BWH
Identifier Type: -
Identifier Source: org_study_id
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