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OpenTrials
Completed

NCT Number: NCT04466566

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

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.

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Key information

Conditions

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline

Other

Saline will serve as the control

Exendin-9,39

Biological

Exendin-9,39 will block the GLP-1 receptor

Primary outcomes

  1. Insulin secretion quantified using the minimal model to generate an index of beta-cell responsivity (Φ)

    Time frame: This will be calculated from the 0-180 minute data of the study

Secondary outcomes

  1. Glucagon secretion measured by immunoassay

    Time frame: This will be averaged over the 0-180 minute data of the study

Sponsors and collaborators

Lead sponsor

Adrian Vella

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2020
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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