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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04466566
Enrollment
21
Registered
2020-07-10
Start date
2022-10-17
Completion date
2025-12-30
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

OTHERSaline

Saline will serve as the control

BIOLOGICALExendin-9,39

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

Sponsors

Adrian Vella
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Glucagon secretion measured by immunoassayThis will be averaged over the 0-180 minute data of the study

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAdrian Vella, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026