AchE Inhibitor and Insulin
AchE
Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus
Started Apr 2017
Typical duration for phase_1 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedStudy Start
First participant enrolled
April 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2018
CompletedFebruary 27, 2019
February 1, 2019
1.7 years
February 21, 2017
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Glucose excursion after IV glucose infusion
-10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes
Study Arms (2)
IVGTT without pyridostigmine
NO INTERVENTIONAn intravenous glucose tolerance test (IVGTT) will be performed without any medication for baseline comparison.
IVGTT with pyridostigmine
ACTIVE COMPARATORAn IVGTT will be performed 2 hours after taking one single dose of pyridostigmine 60 mg
Interventions
single oral dose of 60 mg pyridostigmine tablet
Eligibility Criteria
You may qualify if:
- years and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- American Diabetes Associationcollaborator
Study Sites (1)
Diabetes Research Institute
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria del Pilar Solano, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
February 21, 2017
First Posted
February 24, 2017
Study Start
April 19, 2017
Primary Completion
December 14, 2018
Study Completion
December 14, 2018
Last Updated
February 27, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share