Estrogen and Diabetes

A

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

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

Trial contacts and locations

2

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Central trial contact

Maire Rose Bieck, MS; Ryan Harris, PhD, CES

Data sourced from clinicaltrials.gov

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