Estrogen and Diabetes
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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) |
Dietary Supplement: Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid
Dietary Supplement: Resveratrol
1500 mg trans-resveratrol
Other: Placebo
placebo
|
No Intervention: Healthy control women Healthy women who participate will receive no intervention and serve as controls. |
|
Experimental: 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) |
Dietary Supplement: Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid
Dietary Supplement: Resveratrol
1500 mg trans-resveratrol
Other: Placebo
placebo
|
Outcome Measures
Primary Outcome Measures
- Change in Flow-Mediated Dilation (FMD) [change in FMD at 2hrs]
The change in FMD at ~2hrs from baseline values
Eligibility Criteria
Criteria
Inclusion Criteria:
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Both men and premenopausal
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Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
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All races
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Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)
Exclusion Criteria:
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Clinical diagnosis of hepatic, cardiovascular, or renal disease
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Uncontrolled Diabetes (HbA1c>9%)
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Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
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Proteinuria
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Uncontrolled Hypertension (>140/90 mmHg on therapy)
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Hormonal use of birth control (past 3 months)
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Pregnancy
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Oligomenorrhea
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Direct vasoactive medications (i.e. nitrates)
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Anti-estrogens (i.e. SERMs)
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Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
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Undetectable Anti-Mullerian Hormone (AMH) following screening
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Augusta University | Augusta | Georgia | United States | 30912 |
2 | Georgia Prevention Institute | Augusta | Georgia | United States | 30912 |
Sponsors and Collaborators
- Augusta University
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Ryan Harris, PhD, CES, Augusta University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E2 and D
- 1R01HL137087-01A1