Estrogen, Diabetes, and Endothelial Function (EDEN)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: Placebo patch; Drug: Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release; Drug: Cetrorelix acetate, 0.25 mg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT04418908

10-0591

Details and patient eligibility

About

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 stiffer, and this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study, the investigators examined whether a short-term drop in estrogen levels caused arteries to become stiffer, and explored potential reasons for stiffening arteries.

Full 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 baseline study visit, all participants underwent ovarian sex hormone suppression with GnRHant therapy (cetrorelix acetate, 0.25 mg/day) delivered daily as subcutaneous injections for a 1-week period. Participants were randomized to one of two concurrent intervention groups: transdermal estradiol patch (0.075 mg/day) (+E2) or placebo patch (+PL) and returned for a follow-up visit after 1 week of the intervention. Both study visits included collection of anthropometric measures, a fasting blood sample, measures of arterial stiffness, flow-mediated dilation, and endothelial cells via an intravenous catheter.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• Pregnant and/or breastfeeding
• Have not had a menstrual cycle in the last 6 months

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

GnRHant + E2

Active Comparator group

Description:

Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week.

Treatment:

Drug: Cetrorelix acetate, 0.25 mg/day

Drug: Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release

GnRHant + PL

Placebo Comparator group

Description:

Participants in this arm received GnRHant and a placebo patch for a period of 1 week.

Treatment:

Drug: Cetrorelix acetate, 0.25 mg/day

Drug: Placebo patch