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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine+Sitagliptin | Experimental | Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin |
|
| Glutamine+Placebo | Placebo Comparator | Glutamine 30 g/d (15 g with breakfast and dinner) + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Glutamine 30g +sitagliptin 100mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fructosamine | The blood concentration of the glycemic control marker fructosamine | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry R Greenfield, MD, PhD | Garvan Institute of Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Facility | Sydney | New South Wales | 2010 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21593352 | Result | 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. | |
| 25811109 | Result |
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15 of 22 participants were randomized. Of those not randomized, 7 did not meet the inclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin, Then Placebo | Participants first received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks |
| FG001 | Placebo, Then Sitagliptin | Participants first received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention 4 Weeks |
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| Washout 4-6 Weeks |
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| Second Intervention 4 Weeks |
|
Participants who were randomized to receive either sitagliptin 100 mg tablet or placebo tablet (matching sitagliptin 100 mg)
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| ID | Title | Description |
|---|---|---|
| BG000 | First Received Sitagliptin, Then Placebo | Participants first received Glutamine 30 g/d + Sitagliptin (100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg) for 4 weeks |
| BG001 | First Received Placebo, Then Sitagliptin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 individuals withdrew from the study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postprandial Glucose Area Under the Curve (AUC) | The area under the curve (AUC) of the postprandial glucose following a meal challenge | The primary aim of this randomized crossover study was to determine the glycemic effect of 4 weeks of glutamine (15 bd) supplementation with sitagliptin (100 mg/d) or placebo in type 2 diabetes patients treated with metformin. | Posted | Mean | Standard Deviation | mmol/L*t | 0 to 180 minutes |
|
Adverse events were collected during the 4 weeks treatment with the first arm and then during the 4 weeks of treatment with the second arm. Total of 8 weeks.
Adverse events were collected during physical visits to the Clinical Research Facility at the Garvan Institute of Medical Research. Participants were interviewed by the Study Nurse and asked to report any event or symptom they experienced during each of the 4 weeks treatments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin | Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dorit Samocha-Bonet | Garvan Institute of Medical Research | +61292958309 | d.samochabonet@garvan.org.au |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Glutamine 30g +placebo (matching sitagliptin 100 mg) |
|
| 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. |
| 25412338 | 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. |
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Participants first received Glutamine 30 g/d + Placebo (matching Sitagliptin 100 mg/d) for 4 weeks. After a washout period of 4-6 weeks, they then received Glutamine 30 g/d +Sitagliptin (100 mg) for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 2 individuals withdrew | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 2 individuals withdrew from the study | Count of Participants | Participants |
|
| Region of Enrollment | 2 participants withdrew | Number | participants |
|
|
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| Secondary | Fructosamine | The blood concentration of the glycemic control marker fructosamine | The secondary aim of this randomized crossover study was to determine the glycemic effect of 4 weeks of glutamine (15 bd) supplementation with sitagliptin (100 mg/d) or placebo in type 2 diabetes patients treated with metformin. | Posted | Mean | Standard Deviation | micro mol per litre | 4 weeks |
|
|
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Placebo | Glutamine 30 g/d (15 g with breakfast and dinner) + Placebo | 0 | 13 | 0 | 13 | 0 | 13 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |