Signaling Mechanisms and Vascular Function in Patients With Diabetes Mellitus

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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 (widen).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Ebselen

Criteria

Inclusion Criteria:

• Subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin

Exclusion Criteria:

• 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