Incretin Action in Physiology and Diabetes

Insulin Secretion Clinical Trial

Official title:

Incretin Action in Physiology and Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550548
• Other study ID #: Pro00065698
• Secondary ID: R01DK101991
• Status: Completed
• Phase: Phase 1
• Start date: April 21, 2016
• Est. completion date: April 16, 2021

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy adult volunteers

• fasting plasma glucose value = 95 mg/dL, measured at screening visit

• HbA1c = 5.9%, measured at screening visit

Exclusion Criteria:

• history of diabetes diagnosis, including gestational diabetes

• presence of Type II diabetes mellitus among any first degree family members

• rheumatoid arthritis

• inflammatory bowel disease

• unstable angina or uncompensated heart failure

• pulmonary disorders including COPD and asthma

• malabsorptive GI disease, such as celiac disease, or gastric bypass

• significant hepatic disease

• renal insufficiency (eGFR < 60 mL/kg/min)

• anemia (hematocrit < 34%) as measured at screening visit

• pregnancy

• uncontrolled hypertension

• consumption of daily medications that alter glucose metabolism or GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)

Related Conditions & MeSH terms

• Insulin Secretion

Intervention

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

Locations

Country	Name	City	State
United States	Duke Center for Living	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
David D'Alessio, M.D.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta cell sensitivity	Beta-cell sensitivity for each incretin will equal the slope of the insulin secretion rate divided by the specific incretin level (GLP-1 or GIP)	30 minute infusion periods