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Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00609154
First received: January 23, 2008
Last updated: February 5, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: glucagon like peptide-1
Drug: glucose control
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Insulin biosynthesis rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: November 2007
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Type 2 diabetes
 Drug: glucagon like peptide-1
GLP-1 1 pmole/kg/min
Drug: glucose control
glucose without GLP-1
Experimental: B
non diabetic control, matched
 Drug: glucagon like peptide-1
GLP-1 1 pmole/kg/min
Drug: glucose control
glucose without GLP-1

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Type 2 Diabetes Non diabetic, weight, sex, age matched

Exclusion Criteria:

TZD, metformin, Exenatide, sitagliptin CHF, CAD CRF Anemia

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609154

Contacts
Contact: Cynthia Rivera, RN 718-430-2446 carivera@aecom.yu.edu

Locations
United States, New York
Albert Einstein College of Medicinie Recruiting
Bronx, New York, United States, 10461
Contact: Cynthia Rivera, RN     718-430-2446     carivera@aecom.yu.edu    
Principal Investigator: Daniel Stein, MD            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Merck
Investigators
Principal Investigator: Daniel Stein, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Daniel T. Stein, MD, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00609154     History of Changes
Other Study ID Numbers: 1999-041, Sub-study 4
Study First Received: January 23, 2008
Last Updated: February 5, 2008
Health Authority: United States: Food and Drug Administration
United States: Department of Health and Human Services
United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Type 2 diabetes
Insulin
biosynthesis
Non diabetic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Insulin
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Hypoglycemic Agents
Incretins

ClinicalTrials.gov processed this record on May 21, 2013