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

• Sponsor: Garvan Institute of Medical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00673894
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 79
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Sitagliptin; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man
• Actual Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glutamine+Sitagliptin Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin	Drug: Sitagliptin; Glutamine 30g +sitagliptin 100mg; Other Names: Januvia
Placebo Comparator: Glutamine+Placebo Glutamine 30 g/d (15 g with breakfast and dinner) + placebo	Drug: Placebo; Glutamine 30g +placebo (matching sitagliptin 100 mg)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Fructosamine [4 weeks]

   The blood concentration of the glycemic control marker fructosamine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Facility	Sydney	New South Wales	Australia	2010

Sponsors and Collaborators

• Garvan Institute of Medical Research

Investigators

• Principal Investigator: Jerry R Greenfield, MD, PhD, Garvan Institute of Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Jerry Greenfield, Prof, Garvan Institute of Medical Research
• ClinicalTrials.gov Identifier: NCT00673894
• Other Study ID Numbers: H07/059
• First Posted: May 7, 2008
• Last Update Posted: May 13, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Sitagliptin Phosphate

Study Results

Participant Flow

Pre-assignment Detail	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
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	8	7
COMPLETED	6	7
NOT COMPLETED	2	0
Period Title: First Intervention 4 Weeks
STARTED	6	7
COMPLETED	6	7
NOT COMPLETED	0	0
Period Title: First Intervention 4 Weeks
STARTED	6	7
COMPLETED	6	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	First Received Sitagliptin, Then Placebo	First Received Placebo, Then Sitagliptin	Total
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 Participants	8	7	15
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 37.5%	3 42.9%	6 40%
>=65 years	3 37.5%	4 57.1%	7 46.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (8)	65 (5)	65 (6)
Sex: Female, Male (Count of Participants)
Female	2 25%	2 28.6%	4 26.7%
Male	4 50%	5 71.4%	9 60%
Region of Enrollment (participants) [Number]
Australia	6 75%	7 100%	13 86.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L*t]	1341 (180)	1463 (179)

2. Secondary Outcome

Title	Fructosamine
Description	The blood concentration of the glycemic control marker fructosamine
Time Frame	4 weeks

Outcome Measure Data

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
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
Measure Participants	13	13
Mean (Standard Deviation) [micro mol per litre]	244 (41)	240 (30)

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.
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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Serious Adverse Events
	Sitagliptin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Sitagliptin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.