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Effects of Glutamine on GLP-1 and Insulin Secretion in Man

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Garvan Institute of Medical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00673894
First received: May 6, 2008
Last updated: June 19, 2008
Last verified: June 2008
History of Changes
  Purpose

This study will investigate the effect of glutamine, an amino acid, on GLP-1, insulin and glycaemia in normal lean subjects and patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Glutamine, sitagliptin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Effects of Glutamine on GLP-1, Insulin Secretion and Glycaemia in Man

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Garvan Institute of Medical Research:

Primary Outcome Measures:
  • Post-prandial glucose [ Time Frame: 180 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GLP-1 [ Time Frame: 180 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Glutamine, sitagliptin
    Glutamine 15g and 30g/sitagliptin 100mg
    Other Name: Januvia
Detailed Description:

In this study, will investigate the effect of glutamine, an amino acid, on GLP-1, insulin and glycaemia in normal lean subjects and patients with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We will test the hypothesis that glutamine lowers post-prandial glucose levels. We will also investigate whether sitagliptin modifies this effect.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects (lean) or type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)

Exclusion Criteria:

  • malabsorption, renal or liver disease, using steroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673894

Contacts
Contact: Jerry R Greenfield 612-9295-8217 j.greenfield@garvan.org.au

Locations
Australia, New South Wales
Clinical Research Facility Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Dr J Greenfield, FRACP     612-9295-8100 ext 8217     j.greenfield@garvan.org.au    
Principal Investigator: Jerry Greenfield, FRACP            
Sponsors and Collaborators
Garvan Institute of Medical Research
  More Information

No publications provided by Garvan Institute of Medical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jerry Greenfield, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT00673894     History of Changes
Other Study ID Numbers: H07/059
Study First Received: May 6, 2008
Last Updated: June 19, 2008
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013