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NCT04466566 Clinical Trial

A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics

Healthy Clinical Trial

Official title:
Effect of Genetic Variation in the GLP-1 Receptor on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetic Humans

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04466566
Other study ID # 20-003984
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 17, 2022
Est. completion date December 2024

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study to find out how genetic variations in GLP1R alter insulin secretion, in the fasting state and when blood sugars levels are elevated.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria: - 40 nondiabetic subjects will be recruited. - 20 subjects with the AA genotype at rs3765467 and remainder will have the GG genotype. - Individuals encompassing the age span of 25-65 years. Exclusion Criteria: - Individuals under 25 and over 65 years of age.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Saline
Saline will serve as the control
Biological:
• Exendin-9,39
Exendin-9,39 will block the GLP-1 receptor

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Adrian Vella 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 Insulin secretion quantified using the minimal model to generate an index of beta-cell responsivity (F) This will be calculated from the 0-180 minute data of the study
Secondary Glucagon secretion measured by immunoassay This will be averaged over the 0-180 minute data of the study
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