Estrogen and Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT03436992

Run by

Augusta University

People needed

143

Starts

2018-04-17

Expected to finish

2023-12-31

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Augusta University — Augusta, Georgia, United States
• Georgia Prevention Institute — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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