NCT03681691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 27, 2022

Completed
Last Updated

September 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

September 10, 2018

Results QC Date

July 18, 2022

Last Update Submit

September 1, 2022

Conditions

Diabetes Type 2Dementia

Keywords

women's healthestradiolpostmenopausal

Outcome Measures

Primary Outcomes (5)

  • Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain

    Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET). 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 will be quantified.

    Baseline

  • FDG PET--Whole Brain

    Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET). 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 will be quantified.

    Week 8

  • Acetoacetate Uptake (AcAc) PET--Whole Brain

    Brain metabolism will be measured using PET tracers to examine brain 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 AcAc tracers will be quantified.

    Baseline

  • AcAc PET--Whole Brain

    Brain metabolism will be measured using PET tracers to examine brain 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 AcAc tracers will be quantified.

    Week 8

  • Change in Uptake of Glucose and Ketone Bodies in Whole Brain and Alzheimer's Disease-related Regions of Interest.

    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

    Baseline and 8 weeks

Secondary Outcomes (14)

  • Short-Term Memory Composite Score

    Baseline and Week 8

  • Executive Function Composite Score

    Baseline and Week 8

  • California Verbal Learning Task (CVLT) Long Delay Free Recall

    Baseline and Week 8

  • CVLT Short Delay Free Recall

    Baseline and Week 8

  • Benton Visual Retention Task (BVRT) Total Score

    Baseline and Week 8

  • +9 more secondary outcomes

Other Outcomes (3)

  • Regional Ratio of Ketone/Glucose Uptake

    Baseline and Week 8

  • Number of White Matter Hypertensities

    Baseline and Week 8

  • Number of Microbleeds

    Baseline and Week 8

Study Arms (2)

Post menopausal women with diabetes

EXPERIMENTAL

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

Drug: Estradiol patch

Post menopausal women without diabetes

EXPERIMENTAL

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

Drug: Estradiol patch

Interventions

Estradiol patchDRUG

transdermal 17β-estradiol patch

Also known as: Climara patch
Post menopausal women with diabetesPost menopausal women without diabetes

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Dementia

Interventions

Ortho Evra

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Christina Hugenschmidt, PhD
Organization
Wake Forest University Health Science
chugensc@wakehealth.edu
336.713.4190

Study Officials

  • Christina Hugenschmidt, PhD

    Wake Forest Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 24, 2018

Study Start

May 13, 2019

Primary Completion

July 19, 2021

Study Completion

July 19, 2021

Last Updated

September 27, 2022

Results First Posted

September 27, 2022

Record last verified: 2022-07

Locations

US(1)