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Trial registered on ANZCTR


Registration number
ACTRN12612000488808
Ethics application status
Approved
Date submitted
11/04/2012
Date registered
3/05/2012
Date last updated
3/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does exogenous glucose-dependent insulinotropic polypeptide (GIP) effect gastric emptying and glycaemic response to small intestinal nutrient in critically ill patients?
Scientific title
The effect of exogenous glucose-dependent insulinotropic polypeptide (GIP) on gastric emptying and glucose metabolism in critically ill patients
Secondary ID [1] 280297 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Glucose Control 286253 0
Critical illness 286404 0
Condition category
Condition code
Metabolic and Endocrine 286474 286474 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Drug: Glucose-dependent insulinotropic polypeptide (GIP) at 4pmol.kg.min
Infused intravenously at rate of 1ml/min from 0-360mins
Patients will be studied on 2 consecutive days (i.e. 24 hour washout period)
Intervention code [1] 284649 0
Treatment: Drugs
Comparator / control treatment
Control: 0.9% saline
Infused intravenously at rate of 1ml/min from 0-360mins
Patients will be studied on 2 consecutive days (i.e. 24 hour washout period)
Control group
Placebo

Outcomes
Primary outcome [1] 286923 0
To determine if exogenous glucose-dependent insulinotropic polypeptide (GIP) will lower fasting and nutrient stimulated glycaemia
Timepoint [1] 286923 0
Blood glucose will be measured at 30min intervals between t=0-360min
Secondary outcome [1] 297002 0
To evaluate in the critically ill patient, the effects of exogenous glucose-dependent insulinotropic polypeptide (GIP) on gastric emptying
Timepoint [1] 297002 0
1. Scintigraphy - Measurement of gastric emptying following administration of a test meal labelled with 20MBq 99mTC calcium phytate. Test meal will be given 60mins into the study. Stomach content will be measured at 0, 5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 200 minutes after the meal
2. Octanoate acid breath test - Octanoic acid will be mixed with the test meal and breath samples will be taken initially every 5mins for the first hour, then every 15mins for the remaining 4 hours
Secondary outcome [2] 297003 0
To evaluate in the critically ill patient, the effects of exogenous glucose-dependent insulinotropic polypeptide (GIP) on glucose absorption
Timepoint [2] 297003 0
3-O-methyl-glucose (3-OMG) measurement - 3grams of 3-O-methyl-glucose will be incorporated into the test meal. Blood samples will be taken at time 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300mins after the meal is administered
Secondary outcome [3] 297004 0
To evaluate in the critically ill patient, the effects of exogenous glucose-dependent insulinotropic polypeptide (GIP) on insulin and glucagon secretion
Timepoint [3] 297004 0
1. Insulin will be measured via blood samples taken at time 0, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360min after study commencement
2. Glucagon will be measured via blood samples taken at time 0, 60, 90, 120, 180, 240, 300 and 360min after study commencement
Secondary outcome [4] 297005 0
To evaluate in the critically ill patient, the effects of exogenous glucose-dependent insulinotropic polypeptide (GIP) on endogenous glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) secretion
Timepoint [4] 297005 0
Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) will be measured via blood samples taken at time 0, 60, 90, 120, 180, 240, 300 and 360min after study commencement

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
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of diabetes
Pregnancy
Haemoglobin <80g/L
Contraindication to enteral feeding
Previous surgery to small intestine
Any gastrointestinal surgery during 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 glucose-dependent insulinotropic polypeptide (GIP) and placebo 0.9% saline 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
Recruiting
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] 285071 0
Government body
Name [1] 285071 0
National Health and Medical Research Council
Address [1] 285071 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601

or

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 285071 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] 283934 0
None
Name [1] 283934 0
Address [1] 283934 0
Country [1] 283934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287082 0
Royal Adelaide Hospital Research Ethics Committe
Ethics committee address [1] 287082 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 287082 0
Australia
Date submitted for ethics approval [1] 287082 0
Approval date [1] 287082 0
21/02/2012
Ethics approval number [1] 287082 0
111131

Summary
Brief summary
The primary objective of this study is to establish if exogenous glucose-dependent insulinotropic polypeptide (GIP) has a glucose lowering effect in critically ill patients and whether it effects gastric emptying
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34041 0
Address 34041 0
Country 34041 0
Phone 34041 0
Fax 34041 0
Email 34041 0
Contact person for public queries
Name 17288 0
Palash Kar
Address 17288 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 17288 0
Australia
Phone 17288 0
+61 08 82225649
Fax 17288 0
Email 17288 0
p_kar@hotmail.com
Contact person for scientific queries
Name 8216 0
Palash Kar
Address 8216 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 8216 0
Australia
Phone 8216 0
+61 08 82225649
Fax 8216 0
Email 8216 0
p_kar@hotmail.com

No information has been provided regarding IPD availability
Summary results
No Results