Status:
COMPLETED
Signaling Mechanisms and Vascular Function in Patients With Diabetes Mellitus
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of the study is to learn how blood vessel function is altered by diabetes. We are studying an investigational drug, Ebselen, to see if it can improve the ability of blood vessels to relax ...
Detailed Description
A major cause of death and disability in patients with diabetes mellitus is atherosclerosis. Endothelial dysfunction is an important, if not primary, factor in atherogenesis. Nitric oxide is an import...
Eligibility Criteria
Inclusion
- Subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin
Exclusion
- Any diabetic subject with a HgbA1C level of \<7% or \>11%
- Evidence of atherosclerosis
- symptoms of angina
- symptoms of claudication
- symptoms of cerebrovascular ischemia
- findings of arterial occlusive disease, as would be suggested by decreased pulses, asymmetric blood pressure, bruits or reduced limb pressure measurements
- hypertension defined as a systolic blood pressure \> = 150 mmHg and a diastolic blood pressure \>= 95 mmHg; (allowable blood pressure medications for diabetic subjects include calcium channel blockers, alpha and beta adrenergic blockers, and diuretics)
- hypercholesterolemia, defined as total cholesterol levels greater than 75th percentile for age and sex and LDL cholesterol levels \>130mg/dL.
- renal insufficiency (serum creatinine \>1.5 mg/dL for men; \>1.2 mg/dL for women)
- hepatic dysfunction defined as liver enzyme abnormalities \> two times the upper limit of normal
- chronic pulmonary disease
- congestive heart failure
- pregnancy (or subjects planning to become pregnant);
- history of cigarette smoking within the last five years;
- history of clinically significant coronary artery or cerebrovascular disease (defined as MI or stroke within 6 months, or presence of unstable angina)
- use of any, vasoactive, cardioactive, or non-steroidal anti-inflammatory medications within 24 hours of vascular testing visits
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00762671
Start Date
May 1 1999
End Date
October 1 2007
Last Update
September 30 2008
Active Locations (1)
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1
Brigham and Women's Hosptial
Boston, Massachusetts, United States, 02115