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

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ClinicalTrials.gov Identifier: NCT00673894
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Sitagliptin
Drug: Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details 15 of 22 participants were randomized. Of those not randomized, 7 did not meet the inclusion criteria
Arm/Group Title Sitagliptin, Then Placebo Placebo, Then Sitagliptin
Hide Arm/Group Description 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 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
Period Title: First Intervention 4 Weeks
Started [1] 8 7
Completed 6 7
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             1             0
[1]
First Intervention Duration 4 weeks
Period Title: Washout 4-6 Weeks
Started 6 7
Completed 6 7
Not Completed 0 0
Period Title: Second Intervention 4 Weeks
Started 6 7
Completed 6 7
Not Completed 0 0
Arm/Group Title First Received Sitagliptin, Then Placebo First Received Placebo, Then Sitagliptin Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
Participants who were randomized to receive either sitagliptin 100 mg tablet or placebo tablet (matching sitagliptin 100 mg)
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  50.0%
3
  42.9%
6
  46.2%
>=65 years
3
  50.0%
4
  57.1%
7
  53.8%
[1]
Measure Analysis Population Description: 2 individuals withdrew from the study
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 13 participants
64  (8) 65  (5) 65  (6)
[1]
Measure Analysis Population Description: 2 individuals withdrew
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
Female
2
  33.3%
2
  28.6%
4
  30.8%
Male
4
  66.7%
5
  71.4%
9
  69.2%
[1]
Measure Analysis Population Description: 2 individuals withdrew from the study
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 6 participants 7 participants 13 participants
6 7 13
[1]
Measure Analysis Population Description: 2 participants withdrew
1.Primary Outcome
Title Postprandial Glucose Area Under the Curve (AUC)
Hide Description The area under the curve (AUC) of the postprandial glucose following a meal challenge
Time Frame 0 to 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Glutamine+Sitagliptin Glutamine+Placebo
Hide Arm/Group Description:

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

Sitagliptin: Glutamine 30g +sitagliptin 100mg

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

Placebo: Glutamine 30g +placebo

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: mmol/L*t
1341  (180) 1463  (179)
2.Secondary Outcome
Title Fructosamine
Hide Description The blood concentration of the glycemic control marker fructosamine
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Glutamine+Sitagliptin Glutamine+Placebo
Hide Arm/Group Description:

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

Sitagliptin: Glutamine 30g +sitagliptin 100mg

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

Placebo: Glutamine 30g +placebo

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micro mol per litre
244  (41) 240  (30)
Time Frame 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 Event Reporting Description 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.
 
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin Glutamine 30 g/d (15 g with breakfast and dinner) + Placebo
All-Cause Mortality
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dorit Samocha-Bonet
Organization: Garvan Institute of Medical Research
Phone: +61292958309
EMail: d.samochabonet@garvan.org.au
Layout table for additonal information
Responsible Party: Dr Jerry Greenfield, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT00673894     History of Changes
Other Study ID Numbers: H07/059
First Submitted: May 6, 2008
First Posted: May 7, 2008
Results First Submitted: September 21, 2017
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019