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Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes

Primary Purpose

Healthy, Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Saline

Exendin-9,39

Saline + Intralipid/Heparin

Exendin-9,39 + Intralipid/Heparin

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 - non-diabetic subjects:

Weight-stable, non-diabetic subjects

Exclusion Criteria - non-diabetic subjects:

Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
HbA1c ≥ 6.5%
Use of glucose-lowering agents.
For female subjects: positive pregnancy test at the time of enrollment or study
History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
Active systemic illness or malignancy.
Symptomatic macrovascular or microvascular disease.

Inclusion criteria - diabetic subjects:

Weight-stable, diabetic subjects treated with diet and lifestyle alone or with metformin monotherapy

Exclusion Criteria - diabetic subjects:

Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
Use of any glucose-lowering agent other than metformin.
2 or more fasting glucose values > 250mg/dl on medication or after medication withdrawal.
Unwillingness or inability to withdraw medication for three weeks prior to, and for the duration of the study.
For female subjects: positive pregnancy test at the time of enrollment or study
History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
Active systemic illness or malignancy.
Symptomatic macrovascular or microvascular disease.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Saline

Exendin-9,39

Saline + Intralipid/Heparin

Exendin-9,39 + Intralipid/Heparin

Arm Description

Saline infusion

Exendin-9,39 infusion

Induction of acute insulin resistance during Saline infusion

Induction of acute insulin resistance during Exendin-9,39 infusion

Outcomes

Primary Outcome Measures

Glucagon Concentrations

Measured by immunoassay

Secondary Outcome Measures

Full Information

NCT ID

NCT04466618

First Posted

June 30, 2020

Last Updated

January 4, 2023

Sponsor

Adrian Vella

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04466618

Brief Title

Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes

Official Title

To Determine the Effect of Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

April 15, 2021 (Actual)

Primary Completion Date

December 15, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

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

GLP-1 is a hormone made by the body that promotes the production of insulin in response to eating. However, there is increasing evidence that this hormone might help support the body's ability to produce insulin when diabetes develops. The purpose of this study is to determine the effect of endogenous GLP-1 secretion on insulin secretion in people with and without type 2 diabetes.

6. Conditions and Keywords

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

Healthy, Type 2 Diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Saline infusion

Arm Title

Exendin-9,39

Arm Type

Active Comparator

Arm Description

Exendin-9,39 infusion

Arm Title

Saline + Intralipid/Heparin

Arm Type

Active Comparator

Arm Description

Induction of acute insulin resistance during Saline infusion

Arm Title

Exendin-9,39 + Intralipid/Heparin

Arm Type

Active Comparator

Arm Description

Induction of acute insulin resistance during Exendin-9,39 infusion

Intervention Type

Biological

Intervention Name(s)

Saline

Intervention Description

Saline infused during the study

Intervention Type

Biological

Intervention Name(s)

Exendin-9,39

Intervention Description

Exendin-9,39 infused during the study

Intervention Type

Biological

Intervention Name(s)

Saline + Intralipid/Heparin

Intervention Description

Saline infused during acute insulin resistance

Intervention Type

Biological

Intervention Name(s)

Exendin-9,39 + Intralipid/Heparin

Intervention Description

Exendin-9,39 infused during acute insulin resistance

Primary Outcome Measure Information:

Title

Glucagon Concentrations

Description

Measured by immunoassay

Time Frame

Average concentration over the 0-180minutes of 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 - non-diabetic subjects: Weight-stable, non-diabetic subjects Exclusion Criteria - non-diabetic subjects: Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose). HbA1c ≥ 6.5% Use of glucose-lowering agents. For female subjects: positive pregnancy test at the time of enrollment or study History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. Active systemic illness or malignancy. Symptomatic macrovascular or microvascular disease. Inclusion criteria - diabetic subjects: Weight-stable, diabetic subjects treated with diet and lifestyle alone or with metformin monotherapy Exclusion Criteria - diabetic subjects: Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose). Use of any glucose-lowering agent other than metformin. 2 or more fasting glucose values > 250mg/dl on medication or after medication withdrawal. Unwillingness or inability to withdraw medication for three weeks prior to, and for the duration of the study. For female subjects: positive pregnancy test at the time of enrollment or study History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. Active systemic illness or malignancy. Symptomatic macrovascular or microvascular disease.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Vella

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

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

Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes

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