Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

February 5, 2024 updated by: Albert Einstein College of Medicine
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicinie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic Group
Participants with Type 2 diabetes
Drug: glucagon like peptide-1
GLP-1 1 pmole/kg/min
Other Names:
  • incretin
Dietary supplement: glucose control
glucose without GLP-1
Active Comparator: Non-diabetic Group
Participants who are non-diabetic will serve as control. treatment is matched to experimental group
Drug: glucagon like peptide-1
GLP-1 1 pmole/kg/min
Other Names:
  • incretin
Dietary supplement: glucose control
glucose without GLP-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Biosynthesis Rate
Time Frame: 24 hours
Blood insulin biosynthesis rate
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Daniel T Stein, MD, Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2010

Primary Completion (Actual)

May 13, 2014

Study Completion (Actual)

May 13, 2014

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimated)

February 6, 2008

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1999-041, Sub-study #4
  • Sub-study 4 (Other Identifier: Merck Sharp & Dohme Corp.)
  • R01DK061644-09 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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