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Completed

NCT Number: NCT04418908

Estrogen, Diabetes, and Endothelial Function

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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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Cetrotide, GnRHant

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

Drug

Active estradiol transdermal patch.

Other names: Climara

Placebo Patch

Drug

Placebo patch designed to match active Climara patches.

Primary outcomes

  1. Flow-mediated dilation (FMD) at baseline

    Time frame: 1 week

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

  2. Flow-mediated dilation (FMD) at follow-up

    Time frame: 1 week

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

  3. 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.

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Vascular Disease, Inflammation and Hormones in Women With Type 1 Diabetes

Acronym: EDEN

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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