Vascular Disease, Inflammation and Hormones in Women With Type 1 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Cetrorelix acetate, 0.25 mg/day
- Conditions
- Type 1 Diabetes
- Sponsor
- University of Colorado, Denver
- Enrollment
- 40
- Primary Endpoint
- Flow-mediated dilation (FMD) at follow-up
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 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.
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 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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Pregnant and/or breastfeeding
- •Have not had a menstrual cycle in the last 6 months
Arms & Interventions
GnRHant + E2
Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week.
Intervention: Cetrorelix acetate, 0.25 mg/day
GnRHant + E2
Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week.
Intervention: Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release
GnRHant + PL
Participants in this arm received GnRHant and a placebo patch for a period of 1 week.
Intervention: Cetrorelix acetate, 0.25 mg/day
GnRHant + PL
Participants in this arm received GnRHant and a placebo patch for a period of 1 week.
Intervention: Placebo patch
Outcomes
Primary Outcomes
Flow-mediated dilation (FMD) at follow-up
Time Frame: 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Quantitative immunuofluorescence of endothelial cell proteins at baseline
Time Frame: Baseline
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Quantitative immunuofluorescence of endothelial cell proteins at follow-up
Time Frame: 1 week
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Flow-mediated dilation (FMD) at baseline
Time Frame: 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Change in flow-mediated dilation (FMD)
Time Frame: Baseline and 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion at baseline and follow-up.
Change in quantitative immunuofluorescence of endothelial cell proteins
Time Frame: Baseline and 1 week
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells