NCT04466566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Oct 2022

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

June 30, 2020

Last Update Submit

January 20, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Glucagon secretion measured by immunoassay

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

Study Arms (2)

Saline

PLACEBO COMPARATOR

Saline will be infused during the study

Other: Saline

Exendin-9,39

ACTIVE COMPARATOR

Exendin-9,39 will be infused during the study

Biological: Exendin-9,39

Interventions

Exendin-9,39BIOLOGICAL

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

Exendin-9,39
SalineOTHER

Saline will serve as the control

Saline

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nondiabetic subjects will be recruited.
  • subjects with the AA genotype at rs3765467 and remainder will have the GG genotype.
  • Individuals encompassing the age span of 25-65 years.

You may not qualify if:

  • Individuals under 25 and over 65 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Adrian Vella, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 10, 2020

Study Start

October 17, 2022

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)