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

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ClinicalTrials.gov Identifier: NCT00673894
Recruitment Status : Unknown
Verified June 2008 by Garvan Institute of Medical Research.
Recruitment status was:  Recruiting
First Posted : May 7, 2008
Last Update Posted : June 20, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Glutamine, sitagliptin Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Effects of Glutamine on GLP-1, Insulin Secretion and Glycaemia in Man
Study Start Date : April 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Glutamine, sitagliptin
    Glutamine 15g and 30g/sitagliptin 100mg
    Other Name: Januvia

Outcome Measures

Primary Outcome Measures :
  1. Post-prandial glucose [ Time Frame: 180 min ]

Secondary Outcome Measures :
  1. GLP-1 [ Time Frame: 180 min ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action