Status:
COMPLETED
Estrogen, Diabetes, and Endothelial Function
Lead Sponsor:
University of Colorado, Denver
Conditions:
Type 1 Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk. With aging, the arteries that are located around the heart get ...
Detailed Description
Participants completed two study visits. The baseline study visit occurred during the early follicular phase of the menstrual cycle, confirmed via take-home ovulation testing. On the day of the baseli...
Eligibility Criteria
Inclusion
- Premenopausal
- Euthyroid
- Not currently planning to become pregnant
- Not currently breastfeeding
- No recent history of amenorrhea in the previous 6 months
- Consent to data and specimen banking
- No use of hormonal contraceptives
- Inclusion Criteria, type 1 diabetes only:
- Diagnosis of type 1 diabetes for at least 5 years
- On insulin within a year of diagnosis
- Current insulin therapy
- Hemoglobin A1c \< 9.5%
- No macroalbuminuria (AER \< 200 ug/min)
- Inclusion Criteria, non-diabetic controls only:
- Hemoglobin A1c \< 5.7%
Exclusion
- Pregnant and/or breastfeeding
- Have not had a menstrual cycle in the last 6 months
Key Trial Info
Start Date :
November 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04418908
Start Date
November 24 2010
End Date
October 22 2018
Last Update
June 5 2020
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