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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRHant + E2 | Active Comparator | Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week. |
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| GnRHant + PL | Placebo Comparator | Participants in this arm received GnRHant and a placebo patch for a period of 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrorelix acetate, 0.25 mg/day | Drug | All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow-mediated dilation (FMD) at baseline | FMD will be measured following an intravenous saline infusion and ascorbic acid infusion. | 1 week |
| Flow-mediated dilation (FMD) at follow-up | FMD will be measured following an intravenous saline infusion and ascorbic acid infusion. | 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. | 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 | 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 | 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 | Baseline and 1 week |
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Inclusion Criteria:
Inclusion Criteria, type 1 diabetes only:
Inclusion Criteria, non-diabetic controls only:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet K Snell-Bergeon, PhD, MPH | University of Colorado, Denver | Principal Investigator |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
| C042691 | LHRH, N-acetyl-(4-chlorophenylalanyl)(1)-(4-chlorophenylalanyl)(2)-tryptophyl(3)-arginyl(6)-alanine(10)- |
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Participants were randomized to either receiving a gonadotropin-releasing antagonist (GnRHant) with estradiol add-back (+E2) or placebo (+PL). Investigators and participants were blinded to randomization status until the study was completed.
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| Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release | Drug | Active estradiol transdermal patch. |
|
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| Placebo patch | Drug | Placebo patch designed to match active Climara patches. |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |