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Trial registered on ANZCTR


Registration number
ACTRN12608000562370
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
7/11/2008
Date last updated
7/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of exogenous glucagon-like peptide-1 administration on glucose metabolism and gastric emptying in critically ill patients.
Scientific title
Double-blind randomised placebo cross-over trial of exogenous glucagon-like peptide-1 to establish the effect on glucose metabolism and gastric emptying during gastric feeding in critically ill patients
Secondary ID [1] 252300 0
There is no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 3686 0
Condition category
Condition code
Metabolic and Endocrine 3852 3852 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Glucagon-like peptide-1 (reconstituted in 4%albumin) at 1.2pmol/kg/min will be administered for 360minutes at 1ml/min. Seperated by 24 hours the cross-over treatment is placebo (intravenous 4% Albumin at 1ml/min for 360minutes
Intervention code [1] 3400 0
Treatment: Drugs
Comparator / control treatment
placebo (4% albumin solution intravenous for 360minutes at 1ml/min)
Control group
Active

Outcomes
Primary outcome [1] 4752 0
blood glucose concentration. Measured using bedside glucometer
Timepoint [1] 4752 0
0-6 hours
Primary outcome [2] 4753 0
gastric emptying. Measured using scintigraphic and breath test techniques
Timepoint [2] 4753 0
0-8 hours
Primary outcome [3] 4754 0
nutrient absorption. Measured using absorption of 3-O-Methyl-Glucose.
Timepoint [3] 4754 0
0-4 hours
Secondary outcome [1] 8031 0
Regulatory and counter-regulatory hormone release. Measured using plasma Insulin and glucagon concentrations
Timepoint [1] 8031 0
0-6 hours
Secondary outcome [2] 8032 0
plasma GLP-1 concentration
Timepoint [2] 8032 0
0-6 hours

Eligibility
Key inclusion criteria
critically ill patients and mechanically ventilated suitable for, or receiving, enteral nutrition and likely to stay ventilated for at least 48 hours.
Minimum age
17 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, Contraindication to enteral nutrient administration, Previous surgery on the oesophagus, stomach or duodenum, Any gastrointestinal surgery on this hospital admission and History of diabetes mellitus

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)
Cross-over study. Randomisation is performed by the pharmacy department of the Royal Adelaide Hospital using statistical software. Once the peptide is reconstituted the study drug or placebo is packaged and labelled study drug. The investigator will receive the study drug from the pharmacy department and have no involvement in preparation of solution or randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 3867 0
Government body
Name [1] 3867 0
National Health and Medical Research Council (NHMRC)
Address [1] 3867 0
Level 5, 20 Allara Street
Canberra ACT 2601
Country [1] 3867 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital Intensive Care Unit
Address
Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide
5000 SA
Country
Australia
Secondary sponsor category [1] 3610 0
Individual
Name [1] 3610 0
adam deane
Address [1] 3610 0
Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide 5000
SA
Country [1] 3610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5920 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 5920 0
IMVS Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 5920 0
Australia
Date submitted for ethics approval [1] 5920 0
Approval date [1] 5920 0
01/07/2008
Ethics approval number [1] 5920 0
061229 V3
Ethics committee name [2] 6099 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 6099 0
Ethics committee country [2] 6099 0
Date submitted for ethics approval [2] 6099 0
Approval date [2] 6099 0
30/07/2008
Ethics approval number [2] 6099 0
061229c

Summary
Brief summary
Adequate nutrition is important to allow patients in the Intensive Care Unit the best chance to recover from their illness. The most common method of feeding patients is through a tube into the gut. However, due to their illness many of these patients have very high levels of glucose (sugar) in the bloodstream, which can have a negative effect on their recovery. The purpose of this study is to determine whether a naturally occurring hormone, called Glucagon-like Peptide-1 (GLP-1), can help lower blood glucose levels and improve the outcome of patients in Intensive Care. GLP-1 is a gastrointestinal hormone that is normally released into the bloodstream in response to a meal.
Trial website
Trial related presentations / publications
Deane AM, Chapman MJ, Fraser RJ, Summers MJ, Zaknic AV, Storey JP, Jones KL, Rayner CK, Horowitz M. Effects of exogenous glucagon-like peptide-1 on gastric emptying and glucose absorption in the critically ill: relationship to glycemia. Crit Care Med. 2010 May;38(5):1261-9.
Public notes

Contacts
Principal investigator
Name 28929 0
Dr Adam Deane
Address 28929 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 28929 0
Australia
Phone 28929 0
+618 8222 2818
Fax 28929 0
Email 28929 0
adam.deane@adelaide.edu.au
Contact person for public queries
Name 12086 0
Dr Adam Deane
Address 12086 0
Intensive Care Unit
Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide SA
5000
Country 12086 0
Australia
Phone 12086 0
08 8222-4000
Fax 12086 0
Email 12086 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 3014 0
Dr adam deane
Address 3014 0
Intensive Care Unit
Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide
SA
5000
Country 3014 0
Australia
Phone 3014 0
08 8222-4000
Fax 3014 0
Email 3014 0
adam.deane@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary