Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

NCT ID: NCT00609154

Last Updated: 2024-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-12

Study Completion Date

2014-05-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Diabetic Group

Participants with Type 2 diabetes

Group Type EXPERIMENTAL

glucagon like peptide-1

Intervention Type DRUG

GLP-1 1 pmole/kg/min

glucose control

Intervention Type DIETARY_SUPPLEMENT

glucose without GLP-1

Non-diabetic Group

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

Group Type ACTIVE_COMPARATOR

glucagon like peptide-1

Intervention Type DRUG

GLP-1 1 pmole/kg/min

glucose control

Intervention Type DIETARY_SUPPLEMENT

glucose without GLP-1

Interventions

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glucagon like peptide-1

GLP-1 1 pmole/kg/min

Intervention Type DRUG

glucose control

glucose without GLP-1

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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incretin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel T Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicinie

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Sub-study 4

Identifier Type: OTHER

Identifier Source: secondary_id

R01DK061644-09

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1999-041, Sub-study #4

Identifier Type: -

Identifier Source: org_study_id

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