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Trial record 27 of 1007 for:    Area Under Curve AND insulin

AchE Inhibitor and Insulin (AchE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03063515
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Maria del Pilar Solano, University of Miami

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
Diabetes Mellitus Drug: Pyridostigmine Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : April 19, 2017
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine


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 Name: Mestinon




Primary Outcome Measures :
  1. First phase insulin response to IV glucose infusion [ Time Frame: -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 [ Time Frame: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes ]
    Glucose positive incremental area under the curve



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063515


Locations
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United States, Florida
Diabetes Research Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
American Diabetes Association
Investigators
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Principal Investigator: Maria del Pilar Solano, MD University of Miami

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Responsible Party: Maria del Pilar Solano, Assistant Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT03063515     History of Changes
Other Study ID Numbers: 20161065
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Miami:
Insulin secretion

Additional relevant MeSH terms:
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Insulin
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pyridostigmine Bromide
Cholinesterase Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents