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Trial registered on ANZCTR


Registration number
ACTRN12609000093280
Ethics application status
Approved
Date submitted
4/02/2009
Date registered
10/02/2009
Date last updated
13/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exogenous glucagon-like peptide-1 (GLP-1) attenuates the glycaemic response to small intestinal nutrient in the critically ill.
Scientific title
The effect of exogenous glucagon-like peptide-1 (GLP-1) compared to placebo on glycaemia in critically ill patients during small intestinal feeding
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Glucose 4268 0
Condition category
Condition code
Metabolic and Endocrine 4494 4494 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Glucagon-like peptide-1 at 1.2pmol.kg.min infused at 1ml/min between t=0-270min. Participants will cross-over to the other arm (i.e. GLP-1 to control and vice-versa) on the next consecutive day (as GLP-1 is rapidly metabolised with a t1/2 < 5mins)
Intervention code [1] 3994 0
Treatment: Other
Comparator / control treatment
Cross-over study
Cross-over treatment is 4% albumin infusion (which has no effect on blood glucose) infused at 1ml/min between t=0-270minutes
Control group
Active

Outcomes
Primary outcome [1] 5376 0
Blood glucose during small intestinal feeding (as measured as Area under the curve)
Timepoint [1] 5376 0
Blood glucose will be measured at 15min intervals between t=0-270min
Secondary outcome [1] 9039 0
Plasma Glucagon during infusion of study drug (i.e. GLP-1 or Placebo)
Timepoint [1] 9039 0
t = 30, 60, 90, 150, 210 and 270mins
Secondary outcome [2] 9094 0
Plasma Insulin during infusion of study drug (i.e. GLP-1 or Placebo)
Timepoint [2] 9094 0
t = 30, 60, 90, 150, 210 and 270mins

Eligibility
Key inclusion criteria
Inclusion criteria
Critically ill patients who require artificial ventilation
Likely to be ventilated for >48hrs
Suitable to receive enteral nutrition via naso-jejunal feeding tube
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18
Age>85
Pregnancy
Small bowel obstruction
History of diabetes
Previous surgery on the oesophagus, stomoach or duodenum
Any gastrointestinal surgery on this admission

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)
Patients admitted to the Intensive Care Unit (ICU) of the Royal Adelaide Hospital will be screened. Next of kin will be approached for informed consent. Synthetic GLP-1-(7-36) amide is reconstituted by the Royal Adelaide Hospital department of pharmacy, as a solution in 4% albumin. Randomisation is performed by the department of pharmacy, so that on each study day the investigators receive the study drug in a glass bottle covered by black plastic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Prospective trial of an acute infusion (270min) of GLP-1 vs. placebo to establish if GLP-1 lowers blood glucose in the critically ill
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4451 0
Charities/Societies/Foundations
Name [1] 4451 0
Australian New Zealand College of Anaethetists
Country [1] 4451 0
Australia
Primary sponsor type
Individual
Name
Adam Deane
Address
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 4010 0
None
Name [1] 4010 0
Address [1] 4010 0
Country [1] 4010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6505 0
Royal adelaide Hospital Research Ethics committee
Ethics committee address [1] 6505 0
Level 3
Hanson Insititute
North Terrace
Adelaide SA 5000
Ethics committee country [1] 6505 0
Australia
Date submitted for ethics approval [1] 6505 0
Approval date [1] 6505 0
30/04/2008
Ethics approval number [1] 6505 0
061229b

Summary
Brief summary
The primary objective of this study is to establish if glucagon-like peptide-1 (a hormone released from the gastrointestinal) has an effect on blood sugar levels in patients who are critically ill
Trial website
Trial related presentations / publications
Manuscript published in Critical Care and can be accessed (open access) at http://ccforum.com/content/13/3/R67
Public notes

Contacts
Principal investigator
Name 29248 0
Address 29248 0
Country 29248 0
Phone 29248 0
Fax 29248 0
Email 29248 0
Contact person for public queries
Name 12495 0
Adam Deane
Address 12495 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 12495 0
Australia
Phone 12495 0
+61 8 8222 4000
Fax 12495 0
Email 12495 0
[email protected]
Contact person for scientific queries
Name 3423 0
Adam Deane
Address 3423 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 3423 0
Australia
Phone 3423 0
+61 8 8222 4000
Fax 3423 0
Email 3423 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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