Status:
COMPLETED
Vitamins C and Vitamin E and Cardiovascular Risk
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
American Diabetes Association
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2 diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and anti-oxidative atheroscl...
Detailed Description
This American Diabetes Association research project is to determine why there are discrepant results between individual studies of Vitamin E and C in both animals and humans compared with the results ...
Eligibility Criteria
Inclusion
- The study will enroll subjects, both men and women with type 2 diabetes of at least six months duration. The age of enrolled subjects will range from 21-60 years old. An HbA1c blood test must show that the person's diabetes is under control. Eligible subjects must have normal electrocardiogram tracings and normal hematological, electrolyte and liver laboratory results at screening. Females of childbearing age must agree to use an effective form of birth control throughout the study period.
Exclusion
- Subjects will be excluded if they have known vascular disease, uncontrolled hypertension (\>140/90 mmHg), marked hyperlipidemia (serum low density lipoprotein \> 4.1 mmol/L or serum triglycerides \> 7.8 mmol/L), and a body mass index greater than 40 kg/m2 (range 27-40). Other important exclusion criteria are cigarette smoking, volunteers taking Coumadin, and recent use of antioxidant supplements or aspirin. Females who are pregnant or breastfeeding will be excluded. People cannot participate in this study if they are taking medications (other than antidiabetic medications) which may affect blood sugar.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00362518
Start Date
July 1 2004
End Date
March 1 2008
Last Update
March 12 2024
Active Locations (1)
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1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131