← Back to Search

Hormone Therapy

Estrogen Therapy for Type 1 Diabetes

N/A

Waitlist Available

Led By Ryan Harris, PhD, CES

Research Sponsored by Augusta University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles

Both men and premenopausal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in fmd at 2hrs

Awards & highlights

Study Summary

This trial will investigate if estrogen contributes to heart problems in premenopausal women with diabetes.

Who is the study for?

This trial is for premenopausal women and men with type 1 diabetes, having a normal menstrual cycle (for women) and no severe diabetic complications. Participants should not be on hormonal birth control or have conditions like polycystic ovarian syndrome, uncontrolled hypertension, or cardiovascular diseases.Check my eligibility

What is being tested?

The study aims to see if estrogen affects blood vessel function in women with diabetes by comparing the effects of an antioxidant cocktail, resveratrol (a compound found in grapes), and a placebo (inactive substance).See study design

What are the potential side effects?

Potential side effects may include allergic reactions to ingredients in the antioxidant cocktail or resveratrol, digestive issues such as stomach upset, headaches, dizziness, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My menstrual cycles are regular, lasting 25-35 days for the last 3 cycles.

Select...

I am a man or a woman who has not gone through menopause.

Select...

I have type 1 diabetes and need insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in fmd at 2hrs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in fmd at 2hrs

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in fmd at 2hrs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Flow-Mediated Dilation (FMD)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Women with type 1 diabetesExperimental Treatment3 Interventions

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

Group II: Men with type 1 diabetesExperimental Treatment3 Interventions

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

Group III: Healthy control womenActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antioxidant Cocktail

2011

Completed Phase 2

~290

Resveratrol

2014

Completed Phase 3

~730

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor

210 Previous Clinical Trials

84,885 Total Patients Enrolled

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

3,833 Previous Clinical Trials

47,306,353 Total Patients Enrolled

Ryan Harris, PhD, CES4.7122 ReviewsPrincipal Investigator - Augusta University

Medical School - University of Kansas, Kansas City, Doctor of Medicine

Augusta University, Medical College of Georgia, Residency in Otolaryngology and Head and Neck Surgery

1 Previous Clinical Trials

64 Total Patients Enrolled

5Patient Review

The Dr. and his staff were very friendly and efficient. I would highly recommend them.

Media Library

Estrogen (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03436992 — N/A

Type 1 Diabetes Research Study Groups: Women with type 1 diabetes, Men with type 1 diabetes, Healthy control women

Type 1 Diabetes Clinical Trial 2023: Estrogen Highlights & Side Effects. Trial Name: NCT03436992 — N/A

Estrogen (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03436992 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this clinical trial?

"Yes, according to the clinicaltrials.gov page, this research project is actively seeking participants. First posted on April 17th 2018 and last modified on July 18th 2022; 198 individuals need to be enrolled across two locations."

Answered by AI

Does this scientific experiment offer access to those in their octogenarian years?

"Patients aged between 18 and 40 years are invited to participate in this medical trial."

Answered by AI

Is enrollment still ongoing for this clinical experiment?

"Affirmative. Clinicaltrials.gov data affirms that this medical trial, initially posted on April 17th 2018 and most recently updated 18 July 2022 is actively recruiting for 198 patients at 2 sites."

Answered by AI

What are the criteria for eligibility to partake in this clinical experiment?

"This study is admitting a cohort of 198 individuals aged between 18 and 40 who have diabetes or an autoimmune condition. The patient population must include both male and premenopausal females of all racial backgrounds."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Estrogen and Diabetes

Ryan Harris 2018. "Estrogen and Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03436992.