Estrogen and Diabetes

Sponsor
Augusta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03436992
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
198
2
3
72.5
99
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Antioxidant Cocktail
  • Dietary Supplement: Resveratrol
  • Other: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Estrogen-Mediated Impairments of Vascular Health in Diabetes
Actual Study Start Date :
Apr 17, 2018
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Women with type 1 diabetes

Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)

Dietary Supplement: Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid

Dietary Supplement: Resveratrol
1500 mg trans-resveratrol

Other: Placebo
placebo

No Intervention: Healthy control women

Healthy women who participate will receive no intervention and serve as controls.

Experimental: Men with type 1 diabetes

Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)

Dietary Supplement: Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid

Dietary Supplement: Resveratrol
1500 mg trans-resveratrol

Other: Placebo
placebo

Outcome Measures

Primary Outcome Measures

  1. Change in Flow-Mediated Dilation (FMD) [change in FMD at 2hrs]

    The change in FMD at ~2hrs from baseline values

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Augusta University Augusta Georgia United States 30912
2 Georgia Prevention Institute Augusta Georgia United States 30912

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Ryan Harris, PhD, CES, Augusta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ryan Harris, Associate Professor, Augusta University
ClinicalTrials.gov Identifier:
NCT03436992
Other Study ID Numbers:
  • E2 and D
  • 1R01HL137087-01A1
First Posted:
Feb 19, 2018
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ryan Harris, Associate Professor, Augusta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022