Status:
COMPLETED
Estrogen and Diabetes
Lead Sponsor:
Augusta University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-40 years
Phase:
NA
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT03436992
Start Date
April 17 2018
End Date
December 31 2023
Last Update
February 17 2025
Active Locations (2)
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1
Augusta University
Augusta, Georgia, United States, 30912
2
Georgia Prevention Institute
Augusta, Georgia, United States, 30912