Back to results

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

Primary Purpose

Healthy

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Saline

Exendin-9,39

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Saline

Exendin-9,39

Arm Description

Saline will be infused during the study

Exendin-9,39 will be infused during the study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glucagon secretion measured by immunoassay

Full Information

NCT ID

NCT04466566

First Posted

June 30, 2020

Last Updated

November 21, 2022

Sponsor

Adrian Vella

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04466566

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 17, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Adrian Vella

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Saline will be infused during the study

Arm Title

Exendin-9,39

Arm Type

Active Comparator

Arm Description

Exendin-9,39 will be infused during the study

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

Saline will serve as the control

Intervention Type

Biological

Intervention Name(s)

Exendin-9,39

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Glucagon secretion measured by immunoassay

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Vella, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeanette Laugen

Phone

507-255-5110

laugen.jeanette@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs