Estrogen, Diabetes, and Endothelial Function

Type 1 Diabetes Clinical Trial

— EDEN  

Official title:

Vascular Disease, Inflammation and Hormones in Women With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418908
• Other study ID #: 10-0591
• Status: Completed
• Phase: N/A
• Start date: November 24, 2010
• Est. completion date: October 22, 2018

Study information

• Verified date: June 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 22, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Cetrorelix acetate, 0.25 mg/day
All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day).
• Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release
Active estradiol transdermal patch.
• Placebo patch
Placebo patch designed to match active Climara patches.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation (FMD) at baseline	FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.	1 week
Primary	Flow-mediated dilation (FMD) at follow-up	FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.	1 week
Primary	Change in flow-mediated dilation (FMD)	FMD will be measured following an intravenous saline infusion and ascorbic acid infusion at baseline and follow-up.	Baseline and 1 week
Primary	Quantitative immunuofluorescence of endothelial cell proteins at baseline	Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells	Baseline
Primary	Quantitative immunuofluorescence of endothelial cell proteins at follow-up	Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells	1 week
Primary	Change in quantitative immunuofluorescence of endothelial cell proteins	Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells	Baseline and 1 week