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Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

glucagon like peptide-1

glucose control

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Insulin, biosynthesis, Non diabetic control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Type 2 Diabetes
Non diabetic

Exclusion Criteria:

Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin
Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF)
Anemia

Sites / Locations

Albert Einstein College of Medicinie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diabetic Group

Non-diabetic Group

Arm Description

Participants with Type 2 diabetes

Participants who are non-diabetic will serve as control. treatment is matched to experimental group

Outcomes

Primary Outcome Measures

Insulin biosynthesis rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00609154

First Posted

January 23, 2008

Last Updated

April 21, 2021

Sponsor

Albert Einstein College of Medicine

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00609154

Brief Title

Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Official Title

Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Albert Einstein College of Medicine

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood. We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.

6. Conditions and Keywords

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

Type 2 Diabetes

Keywords

Type 2 diabetes, Insulin, biosynthesis, Non diabetic control

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diabetic Group

Arm Type

Experimental

Arm Description

Participants with Type 2 diabetes

Arm Title

Non-diabetic Group

Arm Type

Active Comparator

Arm Description

Participants who are non-diabetic will serve as control. treatment is matched to experimental group

Intervention Type

Drug

Intervention Name(s)

glucagon like peptide-1

Intervention Description

GLP-1 1 pmole/kg/min

Intervention Type

Dietary Supplement

Intervention Name(s)

glucose control

Intervention Description

glucose without GLP-1

Primary Outcome Measure Information:

Title

Insulin biosynthesis rate

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 Diabetes Non diabetic Exclusion Criteria: Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF) Anemia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Stein, MD

Organizational Affiliation

Albert Einstein College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Albert Einstein College of Medicinie

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

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Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

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