AchE Inhibitor and Insulin
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
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
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.- 20161065