Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study (RDVCGH)

August 9, 2018 updated by: Cyndya Shibao, Vanderbilt University Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37027
        • Cyndya Shibao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Galantamine then Placebo, WW
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)
Drug: Galantamine
Galantamine 4 mg twice a day for 4 weeks
Other Names:
  • Razadyne
Drug: Placebo
Placebo 1 capsule twice a day for 4 weeks
Other Names:
  • Razadyne
Placebo Comparator: Placebo then Galantamine, WW
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)
Drug: Galantamine
Galantamine 4 mg twice a day for 4 weeks
Other Names:
  • Razadyne
Drug: Placebo
Placebo 1 capsule twice a day for 4 weeks
Other Names:
  • Razadyne
Experimental: Galantamine then Placebo, AAW
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)
Drug: Galantamine
Galantamine 4 mg twice a day for 4 weeks
Other Names:
  • Razadyne
Drug: Placebo
Placebo 1 capsule twice a day for 4 weeks
Other Names:
  • Razadyne
Placebo Comparator: Placebo then Galantamine, AAW
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)
Drug: Galantamine
Galantamine 4 mg twice a day for 4 weeks
Other Names:
  • Razadyne
Drug: Placebo
Placebo 1 capsule twice a day for 4 weeks
Other Names:
  • Razadyne

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin sensitivity
Time Frame: 4 weeks
insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Cyndya A Shibao, MD, Vanderbilt University Medical Center, Clinical Pharmacology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141552-specific aim 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No sharing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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