Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001077853
Ethics application status
Approved
Date submitted
17/09/2012
Date registered
9/10/2012
Date last updated
12/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of critical illness on fat absorption: comparative measurements in healthy volunteers
Scientific title
The effect of critical illness on enteral absorption of long chain triglycerides: comparative measurements in healthy volunteers
Secondary ID [1] 281239 0
Nil
Universal Trial Number (UTN)
U1111-1134-5631
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 287431 0
Condition category
Condition code
Metabolic and Endocrine 287766 287766 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 60ml Intraduodenal infusion at 120ml/hr of liquid nutrient mixed with 13C-triolein and 3-OMG infused into healthy volunteers
Intervention code [1] 285705 0
Treatment: Other
Comparator / control treatment
The control group consists of healthy volunteers. This group is age and sex matched with critically ill patients who have previously been studied by the investigators using the same method between 2010 and 2011.
Control group
Historical

Outcomes
Primary outcome [1] 287995 0
The primary outcome will be lipid absorption in the healthy population, which can then be compared to the data that the investigators have already obtained in the critically ill, mechanically ventilated population.
Lipid absorption is derived from end-expiratory breath samples (10mL) for the measurement of the 13C-Triolein by-product, 13CO2, which will be taken throughout the study.
Timepoint [1] 287995 0
At baseline, 5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 minutes after the commencement of the infusion.
Secondary outcome [1] 299225 0
Glucose absorption as derived from the area under the 3-OMG concentration curve, peak concentration and time to peak. This will be measured from venous blood samples(5ml).
Timepoint [1] 299225 0
At baseline, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes after the commencement of the infusion.
Secondary outcome [2] 299226 0
Plasma concentration of motilin measured from venous blood samples (4ml).
Timepoint [2] 299226 0
At baseline, 30 and 240 minutes after the commencement of the infusion.

Eligibility
Key inclusion criteria
Healthy volunteers aged over 17 years.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to give informed consent.
Contraindication to naso-duodenal feeding tube placement.
Previous surgery on the oesophagus, stomach or duodenum.
Any gastrointestinal disease.
History of diabetes mellitus.
Pregnancy.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2012
Actual
5/09/2012
Date of last participant enrolment
Anticipated
Actual
30/01/2014
Date of last data collection
Anticipated
Actual
30/01/2014
Sample size
Target
15
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 5775 0
5000

Funding & Sponsors
Funding source category [1] 286019 0
Government body
Name [1] 286019 0
NHMRC
Country [1] 286019 0
Australia
Primary sponsor type
Individual
Name
Dr Yasmine Ali Abdelhamid
Address
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 284923 0
None
Name [1] 284923 0
Address [1] 284923 0
Country [1] 284923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288068 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 288068 0
Ethics committee country [1] 288068 0
Australia
Date submitted for ethics approval [1] 288068 0
Approval date [1] 288068 0
21/12/2011
Ethics approval number [1] 288068 0
111217

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

Contacts
Principal investigator
Name 34717 0
Dr Yasmine Ali Abdelhamid
Address 34717 0
ICU Research Department,
Royal Adelaide Hospital,
North Terrace, Adelaide, South Australia, 5000
Australia
Country 34717 0
Australia
Phone 34717 0
+61 8 8222 4624
Fax 34717 0
Email 34717 0
[email protected]
Contact person for public queries
Name 17964 0
Dr Yasmine Ali Abdelhamid
Address 17964 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 17964 0
Australia
Phone 17964 0
+61882224624
Fax 17964 0
Email 17964 0
[email protected]
Contact person for scientific queries
Name 8892 0
Dr Yasmine Ali Abdelhamid
Address 8892 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 8892 0
Australia
Phone 8892 0
+61882224624
Fax 8892 0
Email 8892 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.