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Estrogen and Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antioxidant Cocktail
Resveratrol
Placebo
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Estrogen, Diabetes

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Augusta UniversityRecruiting
  • Georgia Prevention InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Women with type 1 diabetes

Healthy control women

Men with type 1 diabetes

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Flow-Mediated Dilation (FMD)
The change in FMD at ~2hrs from baseline values

Secondary Outcome Measures

Full Information

First Posted
February 13, 2018
Last Updated
July 18, 2022
Sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03436992
Brief Title
Estrogen and Diabetes
Official Title
Estrogen-Mediated Impairments of Vascular Health in Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Estrogen, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with type 1 diabetes
Arm Type
Experimental
Arm Description
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Arm Title
Healthy control women
Arm Type
No Intervention
Arm Description
Healthy women who participate will receive no intervention and serve as controls.
Arm Title
Men with type 1 diabetes
Arm Type
Experimental
Arm Description
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidant Cocktail
Intervention Description
Vitamin C, Vitamin E, alpha lipoic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Intervention Description
1500 mg trans-resveratrol
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change in Flow-Mediated Dilation (FMD)
Description
The change in FMD at ~2hrs from baseline values
Time Frame
change in FMD at 2hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maire Rose Bieck, MS
Phone
706-721-5483
Email
mbieck@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Harris, PhD, CES
Phone
706-721-5998
Email
ryharris@augusta.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Harris, PhD, CES
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan A Harris, PhD
Phone
706-721-5998
Email
ryharris@augusta.edu
Facility Name
Georgia Prevention Institute
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Harris, PhD, CES
Phone
706-721-5998
Email
ryharris@augusta.edu
First Name & Middle Initial & Last Name & Degree
Jacob Looney, BS
Phone
706-721-5483
Email
jlooney@augusta.edu

12. IPD Sharing Statement

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Estrogen and Diabetes

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