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The Effect of Glutamine on Systemic Inflammation During Human Experimental Endotoxemia

Primary Purpose

Sepsis, Systemic Inflammation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
alanine-glutamine infusion
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sepsis focused on measuring glutamine inflammation HSP70 sepsis

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy young males

Exclusion Criteria:

  • Any kind of acute or chronic diseases

Sites / Locations

  • Centre of Inflammation and Metabolism, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Plasma-levels of cytokines

Secondary Outcome Measures

Heat shock protein -70 production from BMNCs

Full Information

First Posted
October 24, 2008
Last Updated
October 24, 2008
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00780520
Brief Title
The Effect of Glutamine on Systemic Inflammation During Human Experimental Endotoxemia
Official Title
The Effect of Glutamine Infusion on the Inflammatory Response and HSP-70 in BMNCs During Human Experimental
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Glutamine levels decrease during severe sepsis; this may be associated with increased mortality. The investigators tested the effects of glutamine supplementation on systemic inflammation in a human sepsis model. The investigators found that glutamine levels drops significantly during experimentally induced systemic inflammation. However, glutamine did not affect the degree of inflammation.
Detailed Description
Glutamine levels have been shown to decrease substantially with severe sepsis and this has been connected with increased mortality. Therefore, in the present study, we infused either saline or Alanine-glutamine during an endotoxin challenge and measured parameters related to an immune response, i.e. plasma cytokines and Heat Shock Protein (HSP)-70. Materials and Methods This was a double blind, randomised, placebo-controlled crossover trial in eight healthy young men. The study was performed in random order on two separate days, with a four-week washout period between days. Subjects received an infusion of Alanine-glutamine ( Dipeptiven) at a rate of 0.025 g / (kg BW * h) for 10 hrs or saline. After two hours of infusion subjects received an intravenous bolus of E. coli endotoxin (0.3 ng/kg). Blood samples were collected hourly for the following eight hours. HSP-70 protein content in isolated Blood Mononuclear Cells (BMNCs) was measured by western blotting. Results and Discussion Plasma glutamine was significantly increased during infusion with alanine-glutamine infusion. En-dotoxin caused a reduction in plasma-glutamine during saline infusion as well as during Alanine-glutamine infusion. A significant effect of endotoxin was found on leukocyte subpopulations, tumor necrosis factor-a, interleukin-6, the expression of HSP-70 in BMNCs, temperature, and heart rate. However, no differences were detected between treatments with regard to the effect of endotoxin on any of these parameters. Conclusion Endotoxemia reduces plasma glutamine independently of parenteral infusion of alanine-glutamine. Glutamine does not alter the response of leukocytes, leukocyte subpopulations, IL-6, or TNF-α, or the expression of HSP-70 in BMNCs to endotoxemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Systemic Inflammation
Keywords
glutamine inflammation HSP70 sepsis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
alanine-glutamine infusion
Primary Outcome Measure Information:
Title
Plasma-levels of cytokines
Secondary Outcome Measure Information:
Title
Heat shock protein -70 production from BMNCs

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy young males Exclusion Criteria: Any kind of acute or chronic diseases
Facility Information:
Facility Name
Centre of Inflammation and Metabolism, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19173710
Citation
Andreasen AS, Pedersen-Skovsgaard T, Mortensen OH, van Hall G, Moseley PL, Pedersen BK. The effect of glutamine infusion on the inflammatory response and HSP70 during human experimental endotoxaemia. Crit Care. 2009;13(1):R7. doi: 10.1186/cc7696. Epub 2009 Jan 27.
Results Reference
derived

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The Effect of Glutamine on Systemic Inflammation During Human Experimental Endotoxemia

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