Type 2 Diabetes
Conditions
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.
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.
Interventions
DRUGSitagliptin
Glutamine 30g +sitagliptin 100mg
DRUGPlacebo
Glutamine 30g +placebo (matching sitagliptin 100 mg)
Sponsors
Garvan Institute of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)
Exclusion criteria
* Malabsorption, renal or liver disease, treatment with steroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glucose Area Under the Curve (AUC) | 0 to 180 minutes | The area under the curve (AUC) of the postprandial glucose following a meal challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fructosamine | 4 weeks | The blood concentration of the glycemic control marker fructosamine |
Countries
Australia
Participant flow
Pre-assignment details
15 of 22 participants were randomized. Of those not randomized, 7 did not meet the inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| First Received Placebo, Then Sitagliptin 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 | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention 4 Weeks | Adverse Event | 1 | 0 |
| First Intervention 4 Weeks | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | First Received Placebo, Then Sitagliptin | First Received Sitagliptin, Then Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 5 | 64 years STANDARD_DEVIATION 8 | 65 years STANDARD_DEVIATION 6 |
| Region of Enrollment Australia | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Postprandial Glucose Area Under the Curve (AUC)
The area under the curve (AUC) of the postprandial glucose following a meal challenge
Time frame: 0 to 180 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glutamine+Sitagliptin | Postprandial Glucose Area Under the Curve (AUC) | 1341 mmol/L*t | Standard Deviation 180 |
| Glutamine+Placebo | Postprandial Glucose Area Under the Curve (AUC) | 1463 mmol/L*t | Standard Deviation 179 |
Secondary
Fructosamine
The blood concentration of the glycemic control marker fructosamine
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glutamine+Sitagliptin | Fructosamine | 244 micro mol per litre | Standard Deviation 41 |
| Glutamine+Placebo | Fructosamine | 240 micro mol per litre | Standard Deviation 30 |