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

First Received on May 6, 2008. Last Updated on June 19, 2008 History of Changes

Sponsor:	Garvan Institute of Medical Research
Information provided by:	Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:	NCT00673894

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 I

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glutamine Insulin Sitagliptin Sitagliptin phosphate

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:

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):

Samocha-Bonet D, Wong O, Synnott EL, Piyaratna N, Douglas A, Gribble FM, Holst JJ, Chisholm DJ, Greenfield JR. Glutamine reduces postprandial glycemia and augments the glucagon-like peptide-1 response in type 2 diabetes patients. J Nutr. 2011 Jul;141(7):1233-8. Epub 2011 May 18.

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 February 09, 2012