Estrogen and Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Estrogen-Mediated Impairments of Vascular Health in Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Dietary Supplement: Antioxidant Cocktail
* Dietary Supplement: Resveratrol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with type 1 diabetes<br>Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo) | Dietary Supplement: Antioxidant Cocktail<br>* Vitamin C, Vitamin E, alpha lipoic acid<br>Dietary Supplement: Resveratrol<br>* 1500 mg trans-resveratrol<br>Other: Placebo<br>* placebo<br>|
| No Intervention: Healthy control women<br>Healthy women who participate will receive no intervention and serve as controls. | |
| Experimental: Men with type 1 diabetes<br>Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo) | Dietary Supplement: Antioxidant Cocktail<br>* Vitamin C, Vitamin E, alpha lipoic acid<br>Dietary Supplement: Resveratrol<br>* 1500 mg trans-resveratrol<br>Other: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flow-Mediated Dilation (FMD) | The change in FMD at  2hrs from baseline values | change in FMD at 2hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Estrogen, Diabetes