An interventional study of Cetrorelix acetate, 0.25 mg/day and Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release in Type 1 Diabetes, sponsored by University of Colorado, Denver. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria, type 1 diabetes only:
Inclusion Criteria, non-diabetic controls only:
Exclusion Criteria:
Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week.
Drug: Cetrorelix acetate, 0.25 mg/day · Drug: Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release
Participants in this arm received GnRHant and a placebo patch for a period of 1 week.
Drug: Cetrorelix acetate, 0.25 mg/day · Drug: Placebo patch
All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day).
Also known as: Cetrotide, GnRHant
Active estradiol transdermal patch.
Also known as: Climara
Placebo patch designed to match active Climara patches.
Flow-mediated dilation (FMD) at baseline
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Time frame: 1 week
Flow-mediated dilation (FMD) at follow-up
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Time frame: 1 week
Change in flow-mediated dilation (FMD)
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion at baseline and follow-up.
Time frame: Baseline and 1 week
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
Time frame: Baseline
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
Time frame: 1 week
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
Time frame: Baseline and 1 week
No study locations are listed for this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Colorado, Denver