Overview
It has been proven women with type 1 diabetes have a 2 to 3 fold greater risk of cardiovascular disease (CVD) than men. This study attempts to determine if estrogen from premenopausal women with diabetes contributes to vascular dysfunction.
Study Information
This study is classified as randomized (participants are chosen by chance for treatment), parallel (2 groups receive two different forms of treatment), parallel (2 groups receive two different forms of treatment), and double blind (hidden from investigators and participants). Three interventions will be conducted by randomly assigned men and women with type 1 diabetes. The interventions to be performed are defined as an antioxidant cocktail dietary supplement (Vitamin C, Vitamin E, alpha lipoic acid), a resveratrol dietary supplement (270 mg trans-resveratrol), and a placebo. Healthy women will serve as the control and will not receive an intervention.
Inclusion Criteria
All races of men and premenopausal women (ages 18-40) with a clinical diagnosis of insulin-dependent type 1 diabetes are allowed to participate. There are no additional requirements for interested men. However, the sponsors mandate one additional requirement for women. All interested women participants are required to have experienced a normal menstrual interval of 25 to 45 days in at least 3 of their previous cycles.
Exclusion Criteria
Applicants interested cannot have a clinical diagnosis of hepatic, cardiovascular, or renal disease. While living with insulin-dependent type 1 diabetes is essential, diabetic complications (i.e. macrovascular, microvascular, or autonomic), or uncontrolled diabetes, defined by a HbA1c level greater than 9%) will disqualify interested applicants. They also cannot have proteinuria, oligomenorrhea, polycystic ovarian syndrome, or exhibit uncontrolled hypertension greater than 140/90 mmHg on therapy, Pregnant women or those who used hormonal birth control in the previous 3 months before the study is conducted are excluded. Additionally, they may not participate if they render an undetectable anti-mullerian hormone (AMH) after screening, or treated with direct vasoconstrictive medications (i.e. nitrates) or anti-estrogens (i.e. SERMS).
Sponsors/Collaborators
Augusta University and the National Heart, Lung, and Blood Institute (NHLBI) collaborate as the sponsors of this study.
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