Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000185066
Ethics application status
Approved
Date submitted
13/08/2009
Date registered
2/03/2010
Date last updated
8/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does exogenous glucagon-like peptide-1 (GLP-1) attenuates the glycaemic response to small intestinal nutrient in critically ill patients with pre-existing type-2 diabetes?
Scientific title
The effect of exogenous glucagon-like peptide-1 (GLP-1) compared to placebo on glycaemia in critically ill patients with pre-existing type-2 diabetes during small intestinal feeding
Secondary ID [1] 283868 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type-2 Diabetes 256893 0
Blood Glucose 243520 0
Condition category
Condition code
Metabolic and Endocrine 239818 239818 0 0
Diabetes

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 270 min at 1ml/min. The infusion will commence 30 minutes prior to the commencement of intestinal nutrient infusion. Seperated by 24 hours the cross-over treatment is placebo (intravenous 4% Albumin at 1ml/min for 270 min), again commenced 30 minutes prior to intestinal nutrient infusion
Intervention code [1] 241132 0
Treatment: Drugs
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] 240582 0
Blood glucose during small intestinal feeding (as measured as Area under the curve)
Timepoint [1] 240582 0
4 hours (30-270 min)
Secondary outcome [1] 257211 0
Peak blood glucose
Timepoint [1] 257211 0
actual time between t=30-270 min
Secondary outcome [2] 257212 0
Regulatory and counter-regulatory hormone release. Measured using plasma Insulin and glucagon concentrations
Timepoint [2] 257212 0
Every 30 minutes for the first 150 minutes and thereafter every 60 minutes until 270 min
Secondary outcome [3] 257210 0
Blood glucose (time above 10 mmol/l)
Timepoint [3] 257210 0
actual time. Blood glucose will be monitored every 15 minutes throughout the study period

Eligibility
Key inclusion criteria
Inclusion criteria
Critically ill patients with pre-existing type- 2 diabetes (not requiring insulin prior to hospital) and 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 insulin-requiring 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
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2009
Actual
1/07/2009
Date of last participant enrolment
Anticipated
30/06/2010
Actual
5/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237504 0
Self funded/Unfunded
Name [1] 237504 0
Country [1] 237504 0
Primary sponsor type
Individual
Name
Adam Deane
Address
Intensive Care Unit, Level 4, Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 236984 0
None
Name [1] 236984 0
Address [1] 236984 0
Country [1] 236984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243631 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 243631 0
Ethics committee country [1] 243631 0
Australia
Date submitted for ethics approval [1] 243631 0
Approval date [1] 243631 0
07/11/2008
Ethics approval number [1] 243631 0
061229d

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30053 0
Dr Adam Deane
Address 30053 0
Royal Adelaide Hospital North Terrace Adelaide, SA 5000
Country 30053 0
Australia
Phone 30053 0
+61 8 8222 4000
Fax 30053 0
Email 30053 0
[email protected]
Contact person for public queries
Name 13300 0
Adam Deane
Address 13300 0
Intensive Care Unit Level 4 Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 13300 0
Australia
Phone 13300 0
+61 8 8222 4000
Fax 13300 0
Email 13300 0
[email protected]
Contact person for scientific queries
Name 4228 0
Adam Deane
Address 4228 0
Intensive Care Unit Level 4 Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 4228 0
Australia
Phone 4228 0
+61 8 8222 4000
Fax 4228 0
Email 4228 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.