AchE Inhibitor and Insulin

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT03063515
Collaborator
American Diabetes Association (Other)
12
1
2
19.8
0.6

Study Details

Study Description

Brief Summary

The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and insulin secretion response will be evaluated by measuring insulin and glucose at different time points. The test will be carried out twice, once without and once with the administration of a single dose of Pyridostigmine on two separate days. The investigator hypothesizes that inhibiting AChE will potentiate insulin secretion.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings
Actual Study Start Date :
Apr 19, 2017
Actual Primary Completion Date :
Dec 14, 2018
Actual Study Completion Date :
Dec 14, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: IVGTT without pyridostigmine

An intravenous glucose tolerance test (IVGTT) will be performed without any medication for baseline comparison.

Active Comparator: IVGTT with pyridostigmine

An IVGTT will be performed 2 hours after taking one single dose of pyridostigmine 60 mg

Drug: Pyridostigmine
single oral dose of 60 mg pyridostigmine tablet
Other Names:
  • Mestinon
  • Outcome Measures

    Primary Outcome Measures

    1. First phase insulin response to IV glucose infusion [-10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes]

      Insulin positive incremental area under the curve and the sum of plasma insulin values at 1 minute and 3 minutes after IV glucose infusion

    Secondary Outcome Measures

    1. Glucose excursion after IV glucose infusion [-10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes]

      Glucose positive incremental area under the curve

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 years and older
    Exclusion Criteria:
    • BMI >30 Kg/m2

    • fasting glucose >100

    • Glycohemoglobin (Hemoglobin A1C) 5.7% or more

    • History of asthma

    • Use of medications that may interfere with glucose metabolism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diabetes Research Institute Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami
    • American Diabetes Association

    Investigators

    • Principal Investigator: Maria del Pilar Solano, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria del Pilar Solano, Assistant Professor of Medicine, University of Miami
    ClinicalTrials.gov Identifier:
    NCT03063515
    Other Study ID Numbers:
    • 20161065
    First Posted:
    Feb 24, 2017
    Last Update Posted:
    Feb 27, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Maria del Pilar Solano, Assistant Professor of Medicine, University of Miami
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 27, 2019