Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Galantamine

Criteria

Inclusion Criteria

• Female

• African American or white (race will be self-defined, but only subjects who report both parents of the same race will be included)

• 18-60 years old

• BMI 30-45 Kg/m2

• Not pregnant or breastfeeding

Exclusion Criteria

• Pregnant or breastfeeding

• Diabetes diagnosis (defined by the American Diabetes Association (ADA) criteria)38

• Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy.

• Arrhythmia (first-, second-, and third-degree AV block)

• Significant weight change >5% in the past 3 months

• Impaired hepatic function (AST and/or ALT >1.5X upper limit of normal range)

• Impaired renal function (eGFR <60ml/min)

• Users of strong inhibitors of CYP3A4 or CYP2D6

• Users of other acetylcholinesterase inhibitors such as pyridostigmine or bethanechol

• History of alcohol or drug abuse

• Mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study

• Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

• Steroid use within 6 weeks prior to study entry

• Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult

• Discretion of the investigator