Type 2 DiabetesNCT00673894

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

A study testing Sitagliptin in people with Type 2 Diabetes, run by Garvan Institute of Medical Research at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Sitagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteAustralia
Study dates: Apr 2008to Nov 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)

Who cannot join

Malabsorption, renal or liver disease, treatment with steroids

Trial locations and contacts

1 site in 1 country.

Australia1 site

Clinical Research Facility
Sydney, New South Wales, 2010

Other trials in Australia

About this study

Official title: Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man

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.

Read the 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.

Conditions: Type 2 Diabetes
Being tested: Sitagliptin, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SitagliptinDrug
Also called Januvia
Glutamine 30g +sitagliptin 100mg
PlaceboDrug
Glutamine 30g +placebo (matching sitagliptin 100 mg)

Study groups in NCT00673894
Study group	Role	What they receive
Glutamine+Sitagliptin	Experimental	Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin Receives: Drug: Sitagliptin
Glutamine+Placebo	Placebo comparator	Glutamine 30 g/d (15 g with breakfast and dinner) + placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Postprandial Glucose Area Under the Curve (AUC)
The area under the curve (AUC) of the postprandial glucose following a meal challenge
Measured: 0 to 180 minutes

Secondary outcomes (1)

Fructosamine
The blood concentration of the glycemic control marker fructosamine
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Nov 2014

First posted7 May 2008 (estimated)
Study startApr 2008
Primary completionDec 2011
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00673894
Sponsor's protocol ID: H07/059
Status last verified: Feb 2019
First submitted: 6 May 2008
Last updated: 13 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21593352
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.
PubMed 25811109
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.
PubMed 25412338

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man
ClinicalTrials.gov ID: NCT00673894
Acronym / sponsor ID: H07/059
Conditions: Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Garvan Institute of Medical ResearchUniversity, hospital or other
Study start: Apr 2008 (actual)
Primary completion: Dec 2011 (actual)
Study completion: Nov 2014 (actual)
First posted: 7 May 2008 (estimated)
Results: Posted 13 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Glutamine+Sitagliptin	Experimental	Drug: SitagliptinGlutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin
Glutamine+Placebo	Placebo comparator	Drug: PlaceboGlutamine 30 g/d (15 g with breakfast and dinner) + placebo

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)

Key exclusion criteria (1 listed)

Malabsorption, renal or liver disease, treatment with steroids

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SitagliptinAlso: JanuviaGlutamine 30g +sitagliptin 100mg	Drug	Glutamine+Sitagliptin
PlaceboGlutamine 30g +placebo (matching sitagliptin 100 mg)	Drug	Glutamine+Placebo

Primary outcome

Postprandial Glucose Area Under the Curve (AUC)
Time frame: 0 to 180 minutes
The area under the curve (AUC) of the postprandial glucose following a meal challenge

1 secondary outcome

Fructosamine
Time frame: 4 weeks

Results and safety

Results posted to the registry on 13 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin, Then Placebo	8	6
Placebo, Then Sitagliptin	7	7

Primary outcome: Postprandial Glucose Area Under the Curve (AUC)

Time frame: 0 to 180 minutes. Mean (Standard Deviation). Unit: mmol/L*t

Measure	Glutamine+Sitagliptin n = 13	Glutamine+Placebo n = 13
Value	1341 (180)	1463 (179)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Placebo	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21593352Samocha-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.
Results publication: PubMed 25811109Samocha-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.
Results publication: PubMed 25412338Samocha-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.
Individual participant dataSharing planned: No

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Active, not recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerry R Greenfield, MD, PhD principal investigator

Garvan Institute of Medical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sitagliptin in people with Type 2 Diabetes, run by Garvan Institute of Medical Research at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial Glucose Area Under the Curve (AUC) (time frame: 0 to 180 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00673894, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.