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Completed

NCT Number: NCT03436992

Estrogen and Diabetes

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University, Augusta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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)

Exclusion criteria

  • Clinical diagnosis of hepatic, cardiovascular, or renal disease
  • Uncontrolled Diabetes (HbA1c>9%)
  • Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
  • Proteinuria
  • Uncontrolled Hypertension (>140/90 mmHg on therapy)
  • Hormonal use of birth control (past 3 months)
  • Pregnancy
  • Oligomenorrhea
  • Direct vasoactive medications (i.e. nitrates)
  • Anti-estrogens (i.e. SERMs)
  • Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
  • Undetectable Anti-Mullerian Hormone (AMH) following screening

Treatment and study plan

Antioxidant cocktail

Dietary Supplement

Vitamin C, Vitamin E, alpha lipoic acid

Resveratrol

Dietary Supplement

1500 mg trans-resveratrol

Placebo

Other

placebo

Primary outcomes

  1. FMD/Shear

    Time frame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.

    Flow-Mediated Dilation (FMD) controlled for shear

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Estrogen-Mediated Impairments of Vascular Health in Diabetes

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 19, 2018
Registry last updated
Feb 17, 2025

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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