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

NCT00673894 | Completed Results

• 1 other identifier: H07/059
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Postprandial Glucose Area Under the Curve (AUC)

  The area under the curve (AUC) of the postprandial glucose following a meal challenge

  0 to 180 minutes

Secondary Outcomes (1)

• Fructosamine

  4 weeks

Study Arms (2)

Glutamine+Sitagliptin

EXPERIMENTAL

Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin

Drug: Sitagliptin

Glutamine+Placebo

PLACEBO COMPARATOR

Glutamine 30 g/d (15 g with breakfast and dinner) + placebo

Drug: Placebo

Interventions

Sitagliptin DRUG

Glutamine 30g +sitagliptin 100mg

Also known as: Januvia

Glutamine+Sitagliptin

Placebo DRUG

Glutamine 30g +placebo (matching sitagliptin 100 mg)

Glutamine+Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Malabsorption, renal or liver disease, treatment with steroids

Sponsors & Collaborators

• Garvan Institute of Medical Research: lead

Study Sites (1)

Clinical Research Facility

Sydney, New South Wales, 2010, Australia

Location

Related Publications (3)

• 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. doi: 10.3945/jn.111.139824. Epub 2011 May 18.

  PMID: 21593352 RESULT

• Samocha-Bonet D, Chisholm DJ, Holst JJ, Greenfield JR. L-glutamine and whole protein restore first-phase insulin response and increase glucagon-like peptide-1 in type 2 diabetes patients. Nutrients. 2015 Mar 24;7(4):2101-8. doi: 10.3390/nu7042101.

  PMID: 25811109 RESULT

• Samocha-Bonet D, Chisholm DJ, Gribble FM, Coster AC, Carpenter KH, Jones GR, Holst JJ, Greenfield JR. Glycemic effects and safety of L-Glutamine supplementation with or without sitagliptin in type 2 diabetes patients-a randomized study. PLoS One. 2014 Nov 20;9(11):e113366. doi: 10.1371/journal.pone.0113366. eCollection 2014.

  PMID: 25412338 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Dorit Samocha-Bonet
• Organization: Garvan Institute of Medical Research

d.samochabonet@garvan.org.au

+61292958309

Study Officials

• Jerry R Greenfield, MD, PhD

  Garvan Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: November 1, 2014
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)