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Aldosterone and Vascular Disease in Diabetes Mellitus

NCT00214825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2008-01-03

No results posted yet for this study

Summary

Specific aims for this proposal are to determine in patients with diabetes mellitus the effects of an aldosterone receptor antagonist on:

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).

Conditions

Interventions

DRUG

eplerenone

50 mg daily for 6 weeks with placebo

DRUG

Hydrochlorothiazide

HCTZ 12.5 mg with potassium (10 mEq) daily for 6 weeks

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Gail K Adler, MD, PhD · Brigham and Women's Hospital Boston, MA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00214825 on ClinicalTrials.gov