Estrogen, Diabetes, and Endothelial Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-24

Study Completion Date

2018-10-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GnRHant + E2

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

Group Type ACTIVE_COMPARATOR

Cetrorelix acetate, 0.25 mg/day

Intervention Type DRUG

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

Intervention Type DRUG

Active estradiol transdermal patch.

GnRHant + PL

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

Group Type PLACEBO_COMPARATOR

Cetrorelix acetate, 0.25 mg/day

Intervention Type DRUG

All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day).

Placebo patch

Intervention Type DRUG

Placebo patch designed to match active Climara patches.

Interventions

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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).

Intervention Type DRUG

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

Active estradiol transdermal patch.

Intervention Type DRUG

Placebo patch

Placebo patch designed to match active Climara patches.

Intervention Type DRUG

Other Intervention Names

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Cetrotide GnRHant Climara

Eligibility Criteria

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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

* 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)

* Hemoglobin A1c \< 5.7%