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NCT03436992 Clinical Trial

Estrogen and Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
Estrogen-Mediated Impairments of Vascular Health in Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03436992
Other study ID # E2 and D
Secondary ID 1R01HL137087-01A
Status Completed
Phase N/A
First received
Last updated
Start date April 17, 2018
Est. completion date December 31, 2023

Study information
Verified date February 2024
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date December 31, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid
• Resveratrol
1500 mg trans-resveratrol
Other:
• Placebo
placebo

Locations
Country Name City State
United States Augusta University Augusta Georgia
United States Georgia Prevention Institute Augusta Georgia

Sponsors (2)
Lead Sponsor Collaborator
Augusta University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Flow-Mediated Dilation (FMD) The change in FMD at ~2hrs from baseline values change in FMD at 2hrs
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