NCT03014323

Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Investigators will test the hypothesis that chronic restoration of vagal nerve activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American Women compared to white women.

Detailed description

Investigators will test the hypothesis that chronic restoration of parasympathetic nervous system (PNS) activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American women (AAW) compared to white women (WW). A cross-over study will be performed in matched cohorts of AAW and white women subjected to chronic central acetylcholinesterase inhibition with galantamine versus placebo, given orally over a 4-week period. Insulin sensitivity will be measured using the gold standard hyperinsulinemic-euglycemic clamp. Adipose tissue will be obtained through subcutaneous fat biopsies where F2-isoprostanes will be quantified.

Conditions

• Insulin Sensitivity
• Oxidative Stress

Interventions

Type	Name	Description
DRUG	Galantamine	Galantamine 4 mg twice a day for 4 weeks
DRUG	Placebo	Placebo 1 capsule twice a day for 4 weeks

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2017-01-09
• Last updated: 2018-08-13

Locations

1 site across 1 country: United States