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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2021-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Estrogen, Diabetes, and Endothelial Function

NCT04418908

Type 1 Diabetes

COMPLETED NA

Estrogen and Diabetes

NCT03436992

Diabetes Mellitus, Type 1

COMPLETED NA

Hormone Replacement Therapy and Insulin Action: A Double-Blind, Parallel, Placebo-Controlled Hormone Intervention Study in Postmenopausal Women

NCT00005769

Menopause

UNKNOWN PHASE2

Impact of Estradiol on Endothelial Function in Peri-Menopausal Women

NCT04255160

Perimenopause Vasodilation Estrogen

RECRUITING PHASE4

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

NCT03112226

Cognitive Impairment Estrogen Deficiency Menopause +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Type 2 Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Objective: The primary objective is to determine whether the effects of glucose and ketone body uptake to the brain in response to 8-week administration of transdermal 17β-estradiol differ in postmenopausal women with and without type 2 diabetes.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Post menopausal women with diabetes

8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes

Group Type EXPERIMENTAL

Estradiol patch

Intervention Type DRUG

transdermal 17β-estradiol patch

Post menopausal women without diabetes

8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.

Group Type EXPERIMENTAL

Estradiol patch

Intervention Type DRUG

transdermal 17β-estradiol patch

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Estradiol patch

transdermal 17β-estradiol patch

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Climara patch

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes