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Trial registered on ANZCTR


Registration number
ACTRN12611000735954
Ethics application status
Approved
Date submitted
12/07/2011
Date registered
14/07/2011
Date last updated
7/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exogenous glucose-dependent insulinotropic polypeptide (GIP) in combination with glucagon-like peptide-1 (GLP-1) attenuate the glycaemic response to small intestinal nutrient in critically ill patients?
Scientific title
The effect of exogenous glucose-dependent insulinotropic polypeptide (GIP) in combination with glucagon-like peptide-1 (GLP-1) on glycaemia in critically ill patients
Secondary ID [1] 262603 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Glucose 268297 0
Condition category
Condition code
Metabolic and Endocrine 268430 268430 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Drug: Glucose-dependent insulinotropic polypeptide (GIP)at 2pmol.kg.min & glucagon-like peptide-1 (GLP-1) at 1.2pmol.kg.min
Infused intravenously from 0-270mins
or
Control: 0.9% saline & GLP-1 at 1.2pmol/kg/min
Infused intravenously from 0-270mins
Patients will be studied on consecutive days (i.e. 24 hour washout period)
Intervention code [1] 266952 0
Treatment: Other
Intervention code [2] 266973 0
Treatment: Drugs
Comparator / control treatment
Cross-over study - Subjects will received both study drug and control in a randomised fashion on consecutive days

The control is 0.9% saline & GLP-1 at 1.2pmol/kg/min
Control group
Active

Outcomes
Primary outcome [1] 269188 0
To determine whether the addition of exogenous glucose-dependent insulinotropic polypeptide (GIP) to glucagon-like peptide-1 (GLP-1) has a glucose-lowering effect in critically ill patients (as measured by area under the curve)
Timepoint [1] 269188 0
Blood glucose will be measured at 15min intervals between t=0-270min
Secondary outcome [1] 279091 0
To establish if exogenous GIP, with concurrent GLP-1 has an additive insulinotropic effect in the critically ill.
Timepoint [1] 279091 0
Plasma Insulin measured at t=0, 30, 60, 90, 120, 150, 210 and 270 min

Eligibility
Key inclusion criteria
Mechanically ventilated critically ill patients.
Suitable for, or receiving post-pyloric nutrition.
Likely to stay ventilated for at least 48 hours.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of diabetes.
Pregnancy.
Contraindication to placement of a post-pyloric feeding tube or enteral feeding.
Previous surgery on the small intestine.
Any gastrointestinal surgery during their current hospital 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.
Study drug ,synthetic GIP and GLP-1 and placebo 0.9% saline and synthetic GLP-1 will be reconstituted by the Royal Adelaide Hospital Department of Pharmacy, as a solution in 4% albumin. Randomisation will be performed by the Department of Pharmacy, so that on each study day the investigators receive the study drug in a glass bottle coved by black plastic, therefore allocation concealment is maintained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation by the department of pharmacy.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
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)
Recruitment hospital [1] 1904 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7679 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 267426 0
Charities/Societies/Foundations
Name [1] 267426 0
The Viertel Charitable Foundation - Sylvia and Charles Viertel Charitable Foundation
Address [1] 267426 0
ANZ Trustees
GPO Box 389D
Melbourne
Victoria 3001
Country [1] 267426 0
Australia
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] 266476 0
None
Name [1] 266476 0
Address [1] 266476 0
Country [1] 266476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269400 0
Royal Adelaide Hospital Research Ethics Committe
Ethics committee address [1] 269400 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 269400 0
Australia
Date submitted for ethics approval [1] 269400 0
Approval date [1] 269400 0
31/03/2010
Ethics approval number [1] 269400 0
090819

Summary
Brief summary
The primary objective of this study is to establish if exogenous glucose-dependent insulinotropic polypeptide in combination with glucagon-like peptide-1 (both hormones released from the gastrointestinal tract) has a glucose lowering effect in critically ill patients
Trial website
Trial related presentations / publications
The results from this study were presented at the ADA conference in Chicago and published in an international medical journal.
Public notes

Contacts
Principal investigator
Name 32859 0
Dr Adam Deane
Address 32859 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 32859 0
Australia
Phone 32859 0
+61 8 8222 4000
Fax 32859 0
Email 32859 0
adam.deane@adelaide.edu.au
Contact person for public queries
Name 16106 0
Dr Adam Deane
Address 16106 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 16106 0
Australia
Phone 16106 0
+61 8 8222 4000
Fax 16106 0
Email 16106 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 7034 0
Dr Adam Deane
Address 7034 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 7034 0
Australia
Phone 7034 0
+61 8 8222 4000
Fax 7034 0
Email 7034 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