Status:
COMPLETED
Signaling Mechanisms and Vascular Function in Diabetes Mellitus
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
Ruboxistaurin is being tested to see if it is effective in treating certain diabetic complications, such as diseases of the blood vessels.
Detailed Description
To test the hypothesis that activation of protein kinase C impairs vascular reactivity in patients with diabetes. A major cause of death and disability in patients with diabetes mellitus is atheroscl...
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 :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00761852
Start Date
May 1 1999
End Date
October 1 2007
Last Update
September 30 2008
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