Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

Phase 1

Withdrawn

• Conditions: Insulin Sensitivity; Oxidative Stress
• Interventions: Drug: Galantamine; Drug: Placebo

• Registration Number: NCT03014323
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Galantamine then Placebo, WW	Placebo	4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in white women (WW)
Placebo then Galantamine, WW	Placebo	Placebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks in white women (WW)
Galantamine then Placebo, AAW	Placebo	4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in African American Women (AAW)
Placebo then Galantamine, AAW	Placebo	Placebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks African American Women (AAW)
Placebo then Galantamine, WW	Galantamine	Placebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks in white women (WW)
Galantamine then Placebo, WW	Galantamine	4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in white women (WW)
Galantamine then Placebo, AAW	Galantamine	4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in African American Women (AAW)
Placebo then Galantamine, AAW	Galantamine	Placebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks African American Women (AAW)

Primary Outcome Measures

Name	Time	Method
insulin sensitivity	4 weeks	insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps

Trial Locations

Locations (1)

Cyndya Shibao; 🇺🇸 Nashville, Tennessee, United States