Status:
COMPLETED
Aldosterone and Vascular Disease in Diabetes Mellitus
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Diabetes Mellitus
Endothelial Dysfunction
Eligibility:
All Genders
21-64 years
Phase:
NA
Brief 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 ...
Detailed Description
Recent human and animal studies suggest that activation of the mineralocorticoid receptor (MR) by aldosterone, the final product of the renin-angiotensin-aldosterone system, causes microvascular damag...
Eligibility Criteria
Inclusion
- Men and women (21-64 years old) with type 1 or type 2 diabetes mellitus and albuminuria (over 30 mg/g creatinine).
Exclusion
- Exclusion criteria include: (1) subjects without hypertension who have baseline systolic blood pressure \<100 mmHg, (2) severe hypertension (blood pressure must be well-controlled on 3 antihypertensive agents or \<150/100 mmHg on £2 antihypertensive agents), (3) ischemic changes on resting electrocardiogram, (4) clinical evidence of heart disease, cerebrovascular or peripheral vascular disease, (5) significant cardiac arrhythmias, (6) aortic stenosis, (7) 2nd or 3rd degree atrio-ventricular block, sinus node disease, or symptomatic bradycardia, (8) bronchospastic lung disease with active wheezing, (9) known hypersensitivity to any of the study drugs, (10) any contraindication to MRI, (11) serum creatinine ³ 1.5 mg/dL, (12) serum potassium ³ 5.0 mmol/L, (13) current smoker, (14) Serum transaminases greater than twice the upper limit of normal, (15) a history of gout, (16) pregnancy, and (17) other active medical problems detected by examination or laboratory testing.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00214825
Start Date
August 1 2003
End Date
March 1 2006
Last Update
January 3 2008
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115