NCT03681691

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Diabetes Type 2
• Dementia

Interventions

Type	Name	Description
DRUG	Estradiol patch	transdermal 17β-estradiol patch

Timeline

• Start date: 2019-05-13
• Primary completion: 2021-07-19
• Completion: 2021-07-19
• First posted: 2018-09-24
• Last updated: 2022-09-27
• Results posted: 2022-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study