Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00673894
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research

Brief Summary:
This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin Drug: Placebo Not Applicable

Detailed Description:
In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man
Actual Study Start Date : April 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glutamine+Sitagliptin
Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin
Drug: Sitagliptin
Glutamine 30g +sitagliptin 100mg
Other Name: Januvia

Placebo Comparator: Glutamine+Placebo
Glutamine 30 g/d (15 g with breakfast and dinner) + placebo
Drug: Placebo
Glutamine 30g +placebo (matching sitagliptin 100 mg)




Primary Outcome Measures :
  1. Postprandial Glucose Area Under the Curve (AUC) [ Time Frame: 0 to 180 minutes ]
    The area under the curve (AUC) of the postprandial glucose following a meal challenge


Secondary Outcome Measures :
  1. Fructosamine [ Time Frame: 4 weeks ]
    The blood concentration of the glycemic control marker fructosamine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)

Exclusion Criteria:

  • Malabsorption, renal or liver disease, treatment with steroids

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


Locations
Layout table for location information
Australia, New South Wales
Clinical Research Facility
Sydney, New South Wales, Australia, 2010
Sponsors and Collaborators
Garvan Institute of Medical Research
Investigators
Layout table for investigator information
Principal Investigator: Jerry R Greenfield, MD, PhD Garvan Institute of Medical Research

Publications of Results:
Layout table for additonal information
Responsible Party: Dr Jerry Greenfield, Prof, 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
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for 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