Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000390987
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
14/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Expression of molecules that detect the presence of fat in the small intestine.
Scientific title
Identification and quantification of the fatty acid sensing molecules, CD36, GPR119, GPR120, and GPR 40 in the duodenum of lean and obese humans.
Secondary ID [1] 259998 0
Nil.
Universal Trial Number (UTN)
N/A.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 265653 0
Healthy human physiology 265665 0
Condition category
Condition code
Oral and Gastrointestinal 265785 265785 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 265795 265795 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will undergo endoscopy (as scheduled for clinical reasons). Small intestinal biopsies will be obtained. The duration of the trial will be approximately 1 hour.
Intervention code [1] 264415 0
Not applicable
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266537 0
Expression of mRNA and protein of CD36, GPR119, GPR120 and GPR40 in small intestinal biopsies.
Timepoint [1] 266537 0
Once only.
Secondary outcome [1] 273994 0
Habitual dietary intake, as assessed by the use of a Food Frequency Questionnaire.
Timepoint [1] 273994 0
Once only.

Eligibility
Key inclusion criteria
Patients aged 18-75 years, scheduled to undergo surveillance endoscopy at the Royal Adelaide Hospital.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-diffuse mucosal disease involving the upper gastrointestinal tract, including Crohn's disease, coeliac disease, or ischaemic changes, evident either macroscopically or on histopathological examination of mucosal biopsies, when the latter is clinically indicated.
-gastrointestinal symptoms
-ongoing anticoagulation or bleeding disorder, or use of anticoagulant drugs (e.g. aspirin, clopidogrel)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264884 0
Self funded/Unfunded
Name [1] 264884 0
Country [1] 264884 0
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, Adelaide, SA, 5005
Country
Australia
Secondary sponsor category [1] 263985 0
Individual
Name [1] 263985 0
Dr Tanya Little
Address [1] 263985 0
University of Adelaide Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country [1] 263985 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266840 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 266840 0
Ethics committee country [1] 266840 0
Australia
Date submitted for ethics approval [1] 266840 0
30/01/2011
Approval date [1] 266840 0
11/03/2011
Ethics approval number [1] 266840 0
110207

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

Contacts
Principal investigator
Name 32488 0
Address 32488 0
Country 32488 0
Phone 32488 0
Fax 32488 0
Email 32488 0
Contact person for public queries
Name 15735 0
Dr Tanya Little
Address 15735 0
University of Adelaide Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country 15735 0
Australia
Phone 15735 0
+61 8 8222 0724
Fax 15735 0
+61 8 8223 3870
Email 15735 0
[email protected]
Contact person for scientific queries
Name 6663 0
Dr Tanya Little
Address 6663 0
University of Adelaide Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country 6663 0
Australia
Phone 6663 0
(08) 8222 0724
Fax 6663 0
(08) 8223 3870
Email 6663 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
SourceTitleYear of PublicationDOI
EmbaseCharacterization of duodenal expression and localization of fatty acid-sensing receptors in humans: Relationships with body mass index.2014https://dx.doi.org/10.1152/ajpgi.00134.2014
N.B. These documents automatically identified may not have been verified by the study sponsor.