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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Not applicable
Enrollment
22 participants (actual)
Sponsor
Garvan Institute of Medical Research · Other
Design
Randomized · Quadruple masking
Countries
1 country

Australia

Start
Apr 2008
Primary completion
Dec 2011
Completion
Nov 2014
First posted
7 May 2008 (estimated)
Last update posted
13 May 2019
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008201020122014
  1. N/A

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

    NCT00673894

    Apr 2008 to Nov 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SitagliptinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Glutamine+Sitagliptin

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

  • Placebo comparator

    Glutamine+Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Postprandial Glucose Area Under the Curve (AUC)

    Time frame · 0 to 180 minutes

    Registry description

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

Secondary outcomes(1)
  1. Fructosamine

    Time frame · 4 weeks

    Registry description

    The blood concentration of the glycemic control marker fructosamine

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 0 to 180 minutes

Postprandial Glucose Area Under the Curve (AUC)

GroupValue (mmol/L*t)Spread
Glutamine+Sitagliptin1341180
Glutamine+Placebo1463179
Secondary and other outcome results(1)
Secondary outcomeMean· 4 weeks

Fructosamine

GroupValue (micro mol per litre)Spread
Glutamine+Sitagliptin24441
Glutamine+Placebo24030

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SitagliptinGlutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin0 / 130 / 130 / 13
PlaceboGlutamine 30 g/d (15 g with breakfast and dinner) + Placebo0 / 130 / 130 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultSamocha-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
  • ResultSamocha-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
  • ResultSamocha-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

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin) Exclusion Criteria: * Malabsorption, renal or liver disease, treatment with steroids

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