Antioxidant Use in Diabetes to Reduce Oxidative Stress

• Status: Active, not recruiting
• Trial end date: 2024-06-02
• Target enrollment: 0
• Participant gender: Female

Summary

Dietary supplementation with antioxidant vitamins, such as Vitamin C and Vitamin E, reduces malformation rates in embryos of diabetic animals. However, human trials exploring the benefits of these antioxidant vitamins have produced unsatisfactory results in trials designed to alleviating diabetic retinopathy, cardiovascular disease, and preeclampsia in pregnancies. The investigators hypothesize that more potent, and better-targeted antioxidants, such as N-acetylcysteine (NAC) and Polyunsaturated Fatty Acids(PUFA), will be successful in preventing birth defects in the offspring of women with diabetes.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• hemoglobin a1c <10

• type 1 diabetes

Exclusion Criteria:

• pregnancy

• BMI > 40

• greater than 1 alcoholic beverages per week

• any tobacco use

• prescribed nitroglycerin, HIV protease inhibits, corticosteroids, cephalosporins, or blood thinners

• vascular complications(history of coronary artery disease, cerebral vascular accident, transient ischemic attack, claudication).