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The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE1

The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women

NCT03681691•Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.

Detailed Description

Epidemiological studies suggest there may be an interaction between type 2 diabetes and estrogen in postmenopausal women, such that diabetes may interact with estrogen levels over time to increase risk for dementia. The mechanism for this effect is now known. However, animal research suggests that it may occur through estrogen's effects on cellular metabolism of glucose and ketone bodies. The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.

Eligibility

Age

60 - 80 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Willing to provide written informed consent
•2. Stated willingness to comply with all study procedures and availability for the duration of the study
•3. Female, postmenopausal, aged 60-80
•4. Normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy)
•5. BMI 20-35 kg/m2
•6. No evidence of dementia or mild cognitive impairment (MoCA score \>25)
•7. Able to access reliable transportation to study and intervention visits

Exclusion Criteria

•1. Use of hormone replacement therapy within the past 3 months
•2. History of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression
•3. Presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)
•4. Currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest
•5. Involved in another research study
•6. Contraindications for MRI or PET scanning
•7. Current smoker

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Key Dates

Start Date

May 13, 2019

Primary Completion Date

July 19, 2021

Completion Date

July 19, 2021

Last Updated

September 27, 2022

Enrollment

ACTUAL participants

Conditions

Diabetes Type 2Dementia

Interventions

Estradiol patch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women

Inclusion Criteria

Exclusion Criteria

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