Estrogen and Diabetes

Augusta University

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Dietary Supplement: Antioxidant Cocktail; Dietary Supplement: Resveratrol; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03436992

E2 and D

1R01HL137087-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 3 patient groups

Women with type 1 diabetes

Experimental group

Description:

Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)

Treatment:

Other: Placebo

Dietary Supplement: Resveratrol

Dietary Supplement: Antioxidant Cocktail

Healthy control women

No Intervention group

Description:

Healthy women who participate will receive no intervention and serve as controls.

Men with type 1 diabetes

Experimental group

Description:

Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)

Treatment:

Other: Placebo

Dietary Supplement: Resveratrol

Dietary Supplement: Antioxidant Cocktail