NCT03014323

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

January 3, 2017

Last Update Submit

August 9, 2018

Conditions

Insulin SensitivityOxidative Stress

Keywords

insulin sensitivityAfrican Americanobese

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps

    4 weeks

Study Arms (4)

Galantamine then Placebo, WW

EXPERIMENTAL

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: GalantamineDrug: Placebo

Placebo then Galantamine, WW

PLACEBO COMPARATOR

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: GalantamineDrug: Placebo

Galantamine then Placebo, AAW

EXPERIMENTAL

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: GalantamineDrug: Placebo

Placebo then Galantamine, AAW

PLACEBO COMPARATOR

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: GalantamineDrug: Placebo

Interventions

GalantamineDRUG

Galantamine 4 mg twice a day for 4 weeks

Also known as: Razadyne
Galantamine then Placebo, AAWGalantamine then Placebo, WWPlacebo then Galantamine, AAWPlacebo then Galantamine, WW
PlaceboDRUG

Placebo 1 capsule twice a day for 4 weeks

Also known as: Razadyne
Galantamine then Placebo, AAWGalantamine then Placebo, WWPlacebo then Galantamine, AAWPlacebo then Galantamine, WW

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cyndya Shibao

Nashville, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Insulin ResistanceObesity

Interventions

Galantamine

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Cyndya A Shibao, MD

    Vanderbilt University Medical Center, Clinical Pharmacology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 9, 2017

Study Start

January 1, 2017

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

No sharing

Locations

US(1)