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NCT03436992Completed

Estrogen and Diabetes

Estrogen-Mediated Impairments of Vascular Health in Diabetes

Source: ClinicalTrials.gov · Last updated 17 Feb 2025

Brief summary (registry, in English)

Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.

Status (registry)
Completed
Study type
Interventional
Enrollment
143 (actual)
First submitted
13 Feb 2018
Start date
17 Apr 2018
Primary completion date
1 Sept 2023
Lead sponsor
Augusta University
NCT number
NCT03436992

What you commit to

  • Study type: Interventional
  • Participants enrolled: 143
  • From 17 Apr 2018 to the primary completion date, 1 Sept 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Direct vasoactive medications (i.e. nitrates)

Other illness

  • Clinical diagnosis of hepatic, cardiovascular, or renal disease
  • Uncontrolled Hypertension (\>140/90 mmHg on therapy)
  • Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)

Lab values

  • Uncontrolled Diabetes (HbA1c\>9%)

Other

  • Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
  • Proteinuria
  • Hormonal use of birth control (past 3 months)
  • Pregnancy
  • Oligomenorrhea
  • Anti-estrogens (i.e. SERMs)
  • Undetectable Anti-Mullerian Hormone (AMH) following screening

Who the study is looking for

  • Both men and premenopausal
  • Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
  • All races
  • Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Augusta University
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status
Georgia prevention institute
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.