The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women (E2T2D)
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ClinicalTrials.gov Identifier: NCT03681691 |
Recruitment Status :
Completed
First Posted : September 24, 2018
Last Update Posted : October 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Type 2 Dementia | Drug: Estradiol patch | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women |
Actual Study Start Date : | May 13, 2019 |
Actual Primary Completion Date : | July 19, 2021 |
Actual Study Completion Date : | July 19, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Post menopausal women with diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
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Drug: Estradiol patch
transdermal 17β-estradiol patch
Other Name: Climara patch |
Experimental: Post menopausal women without diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
|
Drug: Estradiol patch
transdermal 17β-estradiol patch
Other Name: Climara patch |
- Change in uptake of glucose and ketone bodies in whole brain and Alzheimer's disease-related regions of interest. [ Time Frame: Baseline and 8 weeks ]Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET) and ketone body (acetoacetate) uptake (AcAc). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG and AcAc tracers will be quantified, as well as uptake of AcAc relative to FDG to find potential regions of compensatory ketone use
- Change in short-term memory and executive function composite scores. [ Time Frame: Baseline and 8 weeks ]A battery of cognitive tasks will be administered before and after estrogen administration. Composite z-scores will be calculated by calculating a z-score for each cognitive task and summing z-scores from -5 (low) to 5 (high) for the tasks designated as short-term memory and executive function.Higher scores denotes better outcomes.

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Ages Eligible for Study: | 60 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Willing to provide written informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, postmenopausal, aged 60-80
- Normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy)
- BMI 20-35 kg/m2
- No evidence of dementia or mild cognitive impairment (MoCA score >25)
- Able to access reliable transportation to study and intervention visits
Exclusion Criteria:
- Use of hormone replacement therapy within the past 3 months
- History of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression
- Presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)
- Currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest
- Involved in another research study
- Contraindications for MRI or PET scanning
- Current smoker

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681691
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Christina Hugenschmidt, PhD | Wake Forest Health Sciences |
Documents provided by Wake Forest University Health Sciences:
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT03681691 |
Other Study ID Numbers: |
IRB00049740 R21AG054955 ( U.S. NIH Grant/Contract ) |
First Posted: | September 24, 2018 Key Record Dates |
Last Update Posted: | October 1, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Undecided at the present time. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
women's health estradiol postmenopausal |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Estradiol Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |