NCT03436992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 17, 2025

Completed
Last Updated

February 17, 2025

Status Verified

January 1, 2025

Enrollment Period

5.4 years

First QC Date

February 13, 2018

Results QC Date

November 18, 2024

Last Update Submit

January 27, 2025

Conditions

Diabetes Mellitus, Type 1

Keywords

Estrogen, Diabetes

Outcome Measures

Primary Outcomes (1)

  • FMD/Shear

    Flow-Mediated Dilation (FMD) controlled for shear

    ~ 2 weeks. Acquired at Menses and Late Follicular phase.

Study Arms (3)

Women with type 1 diabetes

EXPERIMENTAL

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

Dietary Supplement: Antioxidant CocktailDietary Supplement: ResveratrolOther: Placebo

Healthy control women

NO INTERVENTION

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

Men with type 1 diabetes

EXPERIMENTAL

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

Dietary Supplement: Antioxidant CocktailDietary Supplement: ResveratrolOther: Placebo

Interventions

Antioxidant CocktailDIETARY_SUPPLEMENT

Vitamin C, Vitamin E, alpha lipoic acid

Men with type 1 diabetesWomen with type 1 diabetes
ResveratrolDIETARY_SUPPLEMENT

1500 mg trans-resveratrol

Men with type 1 diabetesWomen with type 1 diabetes
PlaceboOTHER

placebo

Men with type 1 diabetesWomen with type 1 diabetes

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Augusta University

Augusta, Georgia, 30912, United States

Location

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Results Point of Contact

Title
Dr. Ryan Harris
Organization
Augusta University
ryharris@augusta.edu
706-721-5483

Study Officials

  • Ryan Harris, PhD, CES

    Augusta University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 19, 2018

Study Start

April 17, 2018

Primary Completion

September 1, 2023

Study Completion

December 31, 2023

Last Updated

February 17, 2025

Results First Posted

February 17, 2025

Record last verified: 2025-01

Locations

US(2)