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Completed

NCT Number: NCT00673894

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Facility

Sydney, New South Wales, 2010, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Malabsorption, renal or liver disease, treatment with steroids

Treatment and study plan

Sitagliptin

Drug

Glutamine 30g +sitagliptin 100mg

Other names: Januvia

Placebo

Drug

Glutamine 30g +placebo (matching sitagliptin 100 mg)

Primary outcomes

  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 outcomes

  1. Fructosamine

    Time frame: 4 weeks

    The blood concentration of the glycemic control marker fructosamine

Sponsors and collaborators

Lead sponsor

Garvan Institute of Medical Research

Other

Registry information

Official study title

Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man

Important dates

Study start
2008
Primary completion
2011
Study completion
2014
First posted
May 7, 2008
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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