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

Primary Purpose

Insulin Sensitivity, Oxidative Stress

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Galantamine
Placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Sensitivity focused on measuring insulin sensitivity, African American, obese

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cyndya Shibao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Galantamine then Placebo, WW

Placebo then Galantamine, WW

Galantamine then Placebo, AAW

Placebo then Galantamine, AAW

Arm Description

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

insulin sensitivity
insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps

Secondary Outcome Measures

Full Information

First Posted
January 3, 2017
Last Updated
August 9, 2018
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03014323
Brief Title
Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study
Acronym
RDVCGH
Official Title
Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No fundings
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Oxidative Stress
Keywords
insulin sensitivity, African American, obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Galantamine then Placebo, WW
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo then Galantamine, WW
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
Galantamine then Placebo, AAW
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo then Galantamine, AAW
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Galantamine
Other Intervention Name(s)
Razadyne
Intervention Description
Galantamine 4 mg twice a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Razadyne
Intervention Description
Placebo 1 capsule twice a day for 4 weeks
Primary Outcome Measure Information:
Title
insulin sensitivity
Description
insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyndya A Shibao, MD
Organizational Affiliation
Vanderbilt University Medical Center, Clinical Pharmacology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cyndya Shibao
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing

Learn more about this trial

Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

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