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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00673894




Registration number
NCT00673894
Ethics application status
Date submitted
6/05/2008
Date registered
7/05/2008
Date last updated
13/05/2019

Titles & IDs
Public title
Effects of Glutamine on GLP-1 and Insulin Secretion in Man
Scientific title
Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man
Secondary ID [1] 0 0
H07/059
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sitagliptin
Treatment: Drugs - Placebo

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

Placebo Comparator: Glutamine+Placebo - Glutamine 30 g/d (15 g with breakfast and dinner) + placebo


Treatment: Drugs: Sitagliptin
Glutamine 30g +sitagliptin 100mg

Treatment: Drugs: Placebo
Glutamine 30g +placebo (matching sitagliptin 100 mg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Postprandial Glucose Area Under the Curve (AUC)
Timepoint [1] 0 0
0 to 180 minutes
Secondary outcome [1] 0 0
Fructosamine
Timepoint [1] 0 0
4 weeks

Eligibility
Key inclusion criteria
- Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Malabsorption, renal or liver disease, treatment with steroids

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Clinical Research Facility - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00673894
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jerry R Greenfield, MD, PhD
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00673894