NCT02550548

Incretin Action in Physiology and Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: David D'Alessio, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This project is designed to advance understanding of the incretin effect in health and disease. This system of gut-islet linkage is essential for normal glucose tolerance, impaired in T2DM, and amenable to therapeutic intervention. However, there are important gaps in understanding incretin function that limit application of this system; this project will address several of these. A secondary, but critical aspect of this research is focus on inter-individual variation in the physiology of the incretin system. This is a novel direction for research in this field and is critical to advancing the concept of individualized medical care in diabetes by establishing whether there is a physiologic basis for predicting the existence of responders and non-responders to incretin therapies. Currently, we have described only Aim 1 from this grant in this protocol registration. While Aim 2 and 3 are described in the grant, Aim 1 will be conducted first and the results from this Aim and / or the publication of other results in the field may affect the approach to Aims 2 and 3.

Conditions

• Insulin Secretion

Interventions

Type	Name	Description
DRUG	GIP infusion	after establishing a hyperglycemic clamp (target: 125 mg/dL) GIP will be infused
DRUG	GLP-1 infusion	after establishing a hyperglycemic clamp (target: 125 mg/dL) GLP-1 will be infused
DRUG	Ex-9 infusion	Ex-9 infusion will be initiated at start of hyperglycemic clamp (target: 125 mg/dL)

Timeline

• Start date: 2016-04-21
• Primary completion: 2021-04-16
• Completion: 2021-04-16
• First posted: 2015-09-15
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States