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N/A N=57 Randomized Double-blind Treatment

Estrogen and Diabetes

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT03436992 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: FMD/Shear — 0.182; 0.206; 0.155; 0.219 %/s^-1

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Antioxidant Cocktail (Dietary_supplement); Resveratrol (Dietary_supplement); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Augusta University
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
FMD/Shear		 0.182; 0.206; 0.155; 0.219 —

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03436992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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