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NCT03681691 · ClinicalTrials.gov registry record · Phase 1
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03681691: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT03681691 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03681691, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Estradiol patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2021-07-19 |
| Phase | Phase 1 |
What the finished NCT03681691 record still lists
NCT03681691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Estradiol patch is the first listed.
NCT03681691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03681691 about?
NCT03681691 is a clinical study titled "The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women". 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 post...
What is the current status of trial NCT03681691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-05-13. Estimated completion is 2021-07-19.
What interventions are being tested in trial NCT03681691?
The interventions under investigation include: Estradiol patch (DRUG).
Who is sponsoring clinical trial NCT03681691?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03681691's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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