Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Insulin Sensitivity, Oxidative Stress

In brief

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.

Key facts

Study ID

NCT03014323

Run by

Vanderbilt University Medical Center

People needed

0

Starts

2017-01-01

Expected to finish

2018-12-01

Last updated by the study team

2018-08-13

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cyndya Shibao — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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