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

Adrian Vella

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Other: Saline; Biological: Exendin-9,39

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04466566

20-003984

R01DK126206 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Saline will be infused during the study

Treatment:

Other: Saline

Exendin-9,39

Active Comparator group

Description:

Exendin-9,39 will be infused during the study

Treatment:

Biological: Exendin-9,39