Trial Outcomes & Findings for Effects of Glutamine on GLP-1 and Insulin Secretion in Man (NCT NCT00673894)

NCT ID: NCT00673894

Last Updated: 2019-05-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 0 to 180 minutes
• Results posted on: 2019-05-13

Participant Flow

15 of 22 participants were randomized. Of those not randomized, 7 did not meet the inclusion criteria

Participant milestones

Measure	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	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
First Intervention 4 Weeks STARTED	8	7
First Intervention 4 Weeks COMPLETED	6	7
First Intervention 4 Weeks NOT COMPLETED	2	0
Washout 4-6 Weeks STARTED	6	7
Washout 4-6 Weeks COMPLETED	6	7
Washout 4-6 Weeks NOT COMPLETED	0	0
Second Intervention 4 Weeks STARTED	6	7
Second Intervention 4 Weeks COMPLETED	6	7
Second Intervention 4 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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	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
First Intervention 4 Weeks Withdrawal by Subject	1	0
First Intervention 4 Weeks Adverse Event	1	0

Baseline Characteristics

2 individuals withdrew from the study

Baseline characteristics by cohort

Measure	First Received Sitagliptin, Then Placebo n=8 Participants 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	First Received Placebo, Then Sitagliptin n=7 Participants 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	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants • 2 individuals withdrew from the study	0 Participants n=7 Participants • 2 individuals withdrew from the study	0 Participants n=13 Participants • 2 individuals withdrew from the study
Age, Categorical Between 18 and 65 years	3 Participants n=6 Participants • 2 individuals withdrew from the study	3 Participants n=7 Participants • 2 individuals withdrew from the study	6 Participants n=13 Participants • 2 individuals withdrew from the study
Age, Categorical >=65 years	3 Participants n=6 Participants • 2 individuals withdrew from the study	4 Participants n=7 Participants • 2 individuals withdrew from the study	7 Participants n=13 Participants • 2 individuals withdrew from the study
Age, Continuous	64 years STANDARD_DEVIATION 8 • n=6 Participants • 2 individuals withdrew	65 years STANDARD_DEVIATION 5 • n=7 Participants • 2 individuals withdrew	65 years STANDARD_DEVIATION 6 • n=13 Participants • 2 individuals withdrew
Sex: Female, Male Female	2 Participants n=6 Participants • 2 individuals withdrew from the study	2 Participants n=7 Participants • 2 individuals withdrew from the study	4 Participants n=13 Participants • 2 individuals withdrew from the study
Sex: Female, Male Male	4 Participants n=6 Participants • 2 individuals withdrew from the study	5 Participants n=7 Participants • 2 individuals withdrew from the study	9 Participants n=13 Participants • 2 individuals withdrew from the study
Region of Enrollment Australia	6 participants n=6 Participants • 2 participants withdrew	7 participants n=7 Participants • 2 participants withdrew	13 participants n=13 Participants • 2 participants withdrew

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Glutamine+Sitagliptin n=13 Participants Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin Sitagliptin: Glutamine 30g +sitagliptin 100mg	Glutamine+Placebo n=13 Participants Glutamine 30 g/d (15 g with breakfast and dinner) + placebo Placebo: Glutamine 30g +placebo
Postprandial Glucose Area Under the Curve (AUC)	1341 mmol/L*t Standard Deviation 180	1463 mmol/L*t Standard Deviation 179

SECONDARY outcome

Timeframe: 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.

The blood concentration of the glycemic control marker fructosamine

Outcome measures

Measure	Glutamine+Sitagliptin n=13 Participants Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin Sitagliptin: Glutamine 30g +sitagliptin 100mg	Glutamine+Placebo n=13 Participants Glutamine 30 g/d (15 g with breakfast and dinner) + placebo Placebo: Glutamine 30g +placebo
Fructosamine	244 micro mol per litre Standard Deviation 41	240 micro mol per litre Standard Deviation 30

Adverse Events

Sitagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dorit Samocha-Bonet

Garvan Institute of Medical Research

Phone: +61292958309

Email: d.samochabonet@garvan.org.au

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place