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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623000233628
Ethics application status
Approved
Date submitted
13/02/2023
Date registered
6/03/2023
Date last updated
6/03/2023
Date data sharing statement initially provided
6/03/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Examining the role of gut taste receptors in food preferences, weight loss, and metabolic improvements after bariatric surgery.
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Scientific title
Examining the role of gut taste receptors in food preferences, weight loss, and metabolic improvements after bariatric surgery.
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Secondary ID [1]
308939
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obesity
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bariatric surgery
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Condition category
Condition code
Metabolic and Endocrine
325937
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0
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Metabolic disorders
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Surgery
326041
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Exposure is bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass). Observation period is during the pre-operative work-up period until 12-months post surgery.
Observation involves food and alcohol preference questionnaires, blood tests, weight record, and gastrointestinal biopsies at 3 timepoints: pre-operative work-up, bariatric surgery, and approximately 12 months (range 6-18 months) post-surgical follow-up.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
No control group. Study observes within-person changes over time.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Preference for highly palatable fatty foods before vs 12 months after bariatric surgery
This will be assessed by the Fat Preference Questionnaire.
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Assessment method [1]
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Timepoint [1]
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Pre-operatively
Day of surgery (after pre-operative very low energy diet [VLED])
12-months post-surgery
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Primary outcome [2]
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Changes in gastrointestinal expression of taste-related genes before vs 12 months after bariatric surgery
This will be assessed through quantitative PCR and protein analysis of taste receptor and taste-related genes in the stomach and small bowel mucosal biopsies.
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Assessment method [2]
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Timepoint [2]
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Pre-operatively
Day of surgery (after pre-operative very low energy diet [VLED])
12-months post-surgery
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Primary outcome [3]
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Preference for highly palatable sweet foods before vs 12 months after bariatric surgery
This will be assessed by the Sweet Taste Questionnaire.
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Assessment method [3]
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Timepoint [3]
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Pre-operatively
Day of surgery (after pre-operative very low energy diet [VLED])
12-months post-surgery
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Secondary outcome [1]
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Alcohol consumption and drinking preferences.
Assessed via The Drinking Behaviour Questionnaire
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Assessment method [1]
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Timepoint [1]
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Pre-operatively
Day of surgery (after pre-operative very low energy diet [VLED])
12-months post-surgery
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Secondary outcome [2]
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Body weight
Measured on calibrated medical weighing scales in kilograms and change from pre-operative to day-of-surgery to post-operative follow-up calculated as percentage of total weight loss.
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Assessment method [2]
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Timepoint [2]
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Pre-operatively
Day of surgery (after pre-operative very low energy diet [VLED])
12-months post-surgery
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Secondary outcome [3]
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Fasting blood glucose
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Assessment method [3]
418295
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Timepoint [3]
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Pre-operatively
Day of surgery (after pre-operative very low energy diet [VLED])
12-months post-surgery
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Secondary outcome [4]
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Fasting lipid profile
Assessed via serum analysis.
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Assessment method [4]
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Timepoint [4]
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Pre-operatively
Day of surgery (after pre-operative very low energy diet [VLED])
12-months post-surgery
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Eligibility
Key inclusion criteria
1. Adults (age 18 years or over)
2. Waiting to undergo sleeve gastrectomy or Roux-en-Y gastric bypass
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Using medication for the treatment of diabetes and/or obesity
2. Waiting to undergo revisional surgery
3. Previous intestinal surgery that has resulted in alteration to stomach or small bowel anatomy
4. Unable to provide informed consent
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Differences in the expression of taste-related genes after (vs before) surgery will be compared with paired Student’s T-tests or Wilcoxon-matched pair tests. Relationships will be examined between changes in gene expression and food preferences, weight loss, blood glucose and lipids using correlation coefficients and regression analyses.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
31/01/2023
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Date of last participant enrolment
Anticipated
31/01/2024
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Actual
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Date of last data collection
Anticipated
31/01/2025
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Actual
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Sample size
Target
50
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421, Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Melbourne
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Address
41 Victoria Parade, Fitzroy, Victoria, 3065
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
314864
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Country [1]
314864
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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St Vincent's Hospital Melbourne
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Ethics committee address [1]
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41 Victoria Parade, Fitzroy, Victoria, 3065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
312391
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Approval date [1]
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24/11/2022
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Ethics approval number [1]
312391
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Summary
Brief summary
An unintended but common outcome of bariatric surgeries is reduced preference for sweet and fatty foods. It is not known why this occurs. This study will examine whether changes in food preferences after bariatric surgery are related to changes in taste receptors in the gut.
In volunteers undergoing sleeve gastrectomy or gastric bypass, food preferences and gut taste receptors will be examined and compared before and 12 months after surgery. Relationships between food preferences, gut taste receptors, weight loss, blood glucose and lipid profile will be examined. This will indicate whether changes in gut taste receptors are related to the effects of bariatric surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Michael Hii
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Address
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St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, Victoria 3065
Melbourne Gastro Oesophageal Surgery
100 Victoria Parade, East Melbourne, Victoria, 3002
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Country
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Australia
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Phone
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+61 3 9416 4418
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Rosalind Walmsley
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Address
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St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, Victoria 3065
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Country
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Australia
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Phone
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+61 03 9906 5625
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Priya Sumithran
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Address
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Department of Medicine, University of Melbourne, St Vincent's Hospital Melbourne
Clinical Sciences Building, Level 4 / 29 Regent Street, Fitzroy, Victoria, 3065
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Country
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Australia
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Phone
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+61 03 9231 2592
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
individual participant data underlying published results will be shared after de-identification
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When will data be available (start and end dates)?
beginning immediately following publication and ending 5 years after main results publication
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Available to whom?
to researchers who provide a methodologically sound proposal
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Available for what types of analyses?
for investigator-initated research
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How or where can data be obtained?
access subject to approval by investigating team (email
[email protected]
)
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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.
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