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NCT04418908·Not applicable·INTERVENTIONAL

Estrogen, Diabetes, and Endothelial Function

CetrorelixOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

40

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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).

DRUG

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

Active estradiol transdermal patch.

DRUG

Placebo patch

Placebo patch designed to match active Climara patches.

Timeline

From registration to results.

  1. First posted

    Jun 5, 2020

  2. Study start

    Nov 24, 2010

  3. Primary completion

    Oct 22, 2018

  4. Study completion

    Oct 22, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Jun 5, 2020

Outcomes

What the study measures.

Primary outcomes

Flow-mediated dilation (FMD) at baseline

Time frame · 1 week

FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.

Flow-mediated dilation (FMD) at follow-up

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.

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

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

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