AchE Inhibitor and Insulin (AchE)

Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Pyridostigmine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Diabetes Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First phase insulin response to IV glucose infusion	Insulin positive incremental area under the curve and the sum of plasma insulin values at 1 minute and 3 minutes after IV glucose infusion	-10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose excursion after IV glucose infusion	Glucose positive incremental area under the curve	-10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Maria del Pilar Solano, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2017
• Primary Completion (ACTUAL): December 14, 2018
• Study Completion (ACTUAL): December 14, 2018

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Insulin secretion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Pyridostigmine Bromide
• Other Study ID Numbers: 20161065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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