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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Garvan Institute of Medical Research.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673894
First Posted: May 7, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Garvan Institute of Medical Research
  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
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

Resource links provided by NLM:


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

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

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

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

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 Submitted: May 6, 2008
First Posted: May 7, 2008
Last Update Posted: October 12, 2017
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