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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Saline; Biological: Exendin-9,39

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Jeanette Laugen; Phone Number: 507-255-5110; Email: laugen.jeanette@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Saline will be infused during the study	Other: Saline; Saline will serve as the control
Active Comparator: Exendin-9,39; Exendin-9,39 will be infused during the study	Biological: Exendin-9,39; Exendin-9,39 will block the GLP-1 receptor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insulin secretion quantified using the minimal model to generate an index of beta-cell responsivity (Φ)	This will be calculated from the 0-180 minute data of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Glucagon secretion measured by immunoassay	This will be averaged over the 0-180 minute data of the study

Collaborators and Investigators

• Sponsor: Adrian Vella
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 20-003984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No