AchE Inhibitor and Insulin

Diabetes Mellitus Clinical Trial

— AchE  

Official title:

Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063515
• Other study ID #: 20161065
• Status: Completed
• Phase: Phase 1
• Start date: April 19, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: February 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Pyridostigmine
single oral dose of 60 mg pyridostigmine tablet

Locations

Country	Name	City	State
United States	Diabetes Research Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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