Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

Oxidative Stress Clinical Trial

— RDVCGH  

Official title:

Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03014323
• Other study ID #: 141552-specific aim 2
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Oxidative Stress

Intervention

Drug:
• Galantamine
Galantamine 4 mg twice a day for 4 weeks
• Placebo
Placebo 1 capsule twice a day for 4 weeks

Locations

Country	Name	City	State
United States	Cyndya Shibao	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity	insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps	4 weeks