Estrogen and Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Dietary Supplement: Antioxidant Cocktail; Dietary Supplement: Resveratrol; Other: Placebo

• Registration Number: NCT03436992
• Lead Sponsor: Augusta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-19
• Study Start: 2018-04-17
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-31
• Results First Submitted: 2024-11-18
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Results First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women with type 1 diabetes	Placebo	Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Women with type 1 diabetes	Resveratrol	Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Men with type 1 diabetes	Resveratrol	Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Men with type 1 diabetes	Placebo	Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Women with type 1 diabetes	Antioxidant Cocktail	Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Men with type 1 diabetes	Antioxidant Cocktail	Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)

Primary Outcome Measures

Name	Time	Method
FMD/Shear	~ 2 weeks. Acquired at Menses and Late Follicular phase.	Flow-Mediated Dilation (FMD) controlled for shear

Trial Locations

Locations (2)

Augusta University; 🇺🇸 Augusta, Georgia, United States

Georgia Prevention Institute; 🇺🇸 Augusta, Georgia, United States