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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
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Dementia Drug: Estradiol patch Phase 1

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.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Christina Hugenschmidt, PhD Wake Forest Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Informed Consent Form  [PDF] April 19, 2021

More Information
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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.

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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
Keywords provided by Wake Forest University Health Sciences:
women's health
estradiol
postmenopausal
Additional relevant MeSH terms:
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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