Estrogen-Mediated Impairments of Vascular Health in Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Augusta University
- Enrollment
- 143
- Locations
- 2
- Primary Endpoint
- FMD/Shear
Study Overview
Brief Summary
Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Both men and premenopausal
- •Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
- •All races
- •Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)
Exclusion Criteria
- •Clinical diagnosis of hepatic, cardiovascular, or renal disease
- •Uncontrolled Diabetes (HbA1c>9%)
- •Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
- •Proteinuria
- •Uncontrolled Hypertension (>140/90 mmHg on therapy)
- •Hormonal use of birth control (past 3 months)
- •Pregnancy
- •Oligomenorrhea
- •Direct vasoactive medications (i.e. nitrates)
- •Anti-estrogens (i.e. SERMs)
- •Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
- •Undetectable Anti-Mullerian Hormone (AMH) following screening
Arms & Interventions
Women with type 1 diabetes
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Intervention: Placebo (Other)
Women with type 1 diabetes
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Intervention: Antioxidant Cocktail (Dietary Supplement)
Healthy control women
Healthy women who participate will receive no intervention and serve as controls.
Men with type 1 diabetes
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Intervention: Placebo (Other)
Men with type 1 diabetes
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Intervention: Antioxidant Cocktail (Dietary Supplement)
Women with type 1 diabetes
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Intervention: Resveratrol (Dietary Supplement)
Men with type 1 diabetes
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Intervention: Resveratrol (Dietary Supplement)
Outcomes
Primary Outcomes
FMD/Shear
Time Frame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.
Flow-Mediated Dilation (FMD) controlled for shear
Secondary Outcomes
No secondary outcomes reported
Investigators
Ryan Harris
Associate Professor
Augusta University