Racial Differences in Vagal Control of Glucose Homeostasis

• Status: Completed
• Trial end date: 2017-10-05
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Doris Duke Charitable Foundation
• Treatments: Galantamine; Heparin; Soybean oil, phospholipid emulsion

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 atrioventricular (AV) block)

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

• Impaired hepatic function (AST and/or Alanine transaminase (ALT) > one and one half times (1.5X) upper limit of normal range)

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

• Users of strong inhibitors of Cytochrome P450 3A4 (CYP3A4) or cytochrome P450, family 2, subfamily D, polypeptide 6 (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