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Trial registered on ANZCTR
Registration number
ACTRN12613000758707
Ethics application status
Approved
Date submitted
4/07/2013
Date registered
8/07/2013
Date last updated
8/07/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of sweet taste receptors, glucose transporters, glucose absorption and gastrointestinal hormones in obesity and after bariatric surgery.
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Scientific title
Evaluation of sweet taste receptors, glucose transporters, glucose absorption and gastrointestinal hormones in obesity and after bariatric surgery.
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Secondary ID [1]
282775
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none
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Universal Trial Number (UTN)
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Trial acronym
STR study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
289527
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Laparoscopic adjustable gastric banding (LAGB) and Roux-en-Y Gastric Bypass (RYGB) surgery
289528
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Diabetes Mellitus
289529
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Condition category
Condition code
Diet and Nutrition
289853
289853
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0
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Obesity
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Surgery
289854
289854
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0
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Other surgery
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Oral and Gastrointestinal
289855
289855
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1 - Patients who have previously had bariatric surgery
After inserting a thin endoscope through the nose to the duodenum, 3 biopsies will be taken. A glucose solution (30g glucose and 3g #-OMG) will then be infused into the duodenum for 30 minutes. We will collect another 3 biopsies at the end of the infusion. After 30 minutes of glucose infusion, the endoscope will be removed. Blood samples will be taken at various timepoints throughout the study to measure levels of glucose, 3-OMG, and hormones produced in response to glucose.
Arm 2
Obese patients will undergo the same procedure as those in Arm 1, but will have the procedure done twice, once before and once after a two week Optifast diet (Taking one satchet of Optifast dietary supplemement (different flavoured shakes) 3x daily for two weeks) Apart from two cups of low starch vegetables daily and calorie free fluids, this will be all they will consume for the two week period. Optifast products are classified as very low calorie diets (also known as VLEDs or very low energy diets) have been shown to be very effective in the treatment of obesity, with weekly weight losses averaging approximately 2.0kg in the first 4-6 weeks, providing greater initial weight loss than other forms of calorie restriction.
Each 54g satchet of Optifast dietary supplement contains:
Skimmed Milk Powder, Calcium Caseinate, Sodium Caseinate, Inulin, Maltodextrin (Corn), Vegetable Oils (Canola, Sunflower), Fructose, Sugar, Coffee Extract, Minerals (Potassium Citrate, Magnesium Carbonate, Potassium Phosphate, Sodium Chloride, Ferric Pyrophosphate, Zinc Sulphate, Copper Gluconate,Tricalcium Phosphate, Manganese Sulphate, Sodium Fluoride, Chromium Chloride, Sodium Selenite, Sodium Molybdate, Potassium Iodide), Glucose Syrup (Corn, Wheat Or Potato), Medium Chain Triglycerides, Flavour, Fish Oil, Corn Starch, Vegetable Gum (414), Sweeteners (Aspartame, Acesulfame Potassium), Emulsifiers (Soy Lecithin, 472c, 471), Vitamins (Ascorbic Acid, Vitamin E Acetate, Nicotinamide, Calcium Pantothenate, Pyridoxine Hydrochloride, Thiamin Hydrochloride, Riboflavin, Vitamin A Acetate, Folic Acid, Biotin, Phytonadione, Cholecalciferol, Cyanocobalamin), Antioxidants (304, 307). Contains Milk, Soy, Wheat and Fish. Contains Phenylalanine. Made on equipment that also processes products containing Egg and Celery.
To Monitor adherance to the diet a weekly phone call is made to see how they are progressing with their diet, and also weight is measured before and after the two weeks to monitor weight loss.
Arm 3/Healthy control
In the healthy volunteers, the same procedure is performaed as the other arms. After inserting a thin endoscope through the nose to the duodenum, 3 biopsies will be taken. A glucose solution (30g glucose and 3g #-OMG) will then be infused into the duodenum for 30 minutes. We will collect another 3 biopsies at the end of the infusion. After 30 minutes of glucose infusion, the endoscope will be removed. Blood samples will be taken at various timepoints throughout the study to measure levels of glucose, 3-OMG, and hormones produced in response to glucose.
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Intervention code [1]
287444
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Treatment: Other
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Intervention code [2]
287445
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Lifestyle
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Comparator / control treatment
Healthy control
In the healthy volunteers, the same procedure is performaed as the other arms. After inserting a thin endoscope through the nose to the duodenum, 3 biopsies will be taken. A glucose solution (30g glucose and 3g #-OMG) will then be infused into the duodenum for 30 minutes. We will collect another 3 biopsies at the end of the infusion. After 30 minutes of glucose infusion, the endoscope will be removed. Blood samples will be taken at various timepoints throughout the study to measure levels of glucose, 3-OMG, and hormones produced in response to glucose.
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Control group
Active
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Outcomes
Primary outcome [1]
289916
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Small intestinal sweet taste receptors (T1R2, T1R3, Gagust and TRPM5) during fasting and following 30 minutes of glucose stimulation measured by biopsies taken during endoscopy
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Assessment method [1]
289916
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Timepoint [1]
289916
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3 biopsies taken at t=0min and 30min
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Primary outcome [2]
289917
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Small intestinal carbohydrate transporters (SGLT1 and GLUT2) during fasting and following 30 minute of glucose stimulation as measured by biopsies taken at various timpoints during endoscopy.
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Assessment method [2]
289917
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Timepoint [2]
289917
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3 biopsies taken at t=0min and 30min
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Primary outcome [3]
289918
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Glucose absorption (measured using 3-OMG concentrations (from blood sample) area under curves 0-240 min)
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Assessment method [3]
289918
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Timepoint [3]
289918
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blood samples taken at t = 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 mins.
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Secondary outcome [1]
303567
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The relationships between sweet taste receptors, carbohydrate transporters, glucose absorption and release of incretin hormones (GLP-1, PYY, CCK and insulin).
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Assessment method [1]
303567
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Timepoint [1]
303567
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This is analysed after all data collection is complete
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Eligibility
Key inclusion criteria
Obese patients - BMI > 40kg/m2
Bariatric patients - RYGB or LAGB surgery > 12 months ago
Healthy volunteers - BMI < 40kg/m2
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
History of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history)
Medication that may influence gastrointestinal function
History of surgery to the gastrointestinal tract apart from the RYGB or LAGB
Female patients not using appropriate contraceptive method (ie oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device, Norplant method)
Pregnant and/or breastfeeding mothers
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Pharmacokinetics / pharmacodynamics
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/01/2012
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Actual
12/01/2012
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Date of last participant enrolment
Anticipated
31/10/2013
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
1195
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The Royal Adelaide Hospital - Adelaide
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Funding & Sponsors
Funding source category [1]
287544
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Hospital
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Name [1]
287544
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Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
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Address [1]
287544
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Department of Gastroenterology and Hepatology, Level 7 Q7 North Wing Royal Adelaide Hospital North Terrace Adelaide SA 5000
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Country [1]
287544
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Australia
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Primary sponsor type
Individual
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Name
Dr. Nam Nguyen
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Address
Department of Gastroenterology and Hepatology
Level 7 Q7 North Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
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Country
Australia
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Secondary sponsor category [1]
286296
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Hospital
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Name [1]
286296
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Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
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Address [1]
286296
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Department of Gastroenterology and Hepatology Level 7 Q7 North Wing Royal Adelaide Hospital North Terrace Adelaide SA 5000
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Country [1]
286296
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289525
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Royal Adelaide Hospital Reserach Ethics Comittee
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Ethics committee address [1]
289525
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The Royal Adelaide Hospital Research Ethics Committee, Level 3, Hanson Institute IMVS Building North Terrace Adelaide SA 5000
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Ethics committee country [1]
289525
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Australia
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Date submitted for ethics approval [1]
289525
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Approval date [1]
289525
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02/05/2011
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Ethics approval number [1]
289525
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110427
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Summary
Brief summary
The purpose of this study is to explore the importance of gut sweet taste sensors in the regulation of sugar control, appetite and body weight during health, obesity and after bariatric surgery. The findings of the current study may provide further insights into the mechanisms underlying the development of obesity and diabetes mellitus, which, in turn, can have a great potential therapeutic implication. Hypothesis: We hypothesise that the number of these sweet taste receptors will be markedly reduced in the small intestine of morbidly obese patients but will be increased after bariatric surgery, leading to increased incretin responses and subsequently, better glucose control and body weight (via high GLP-1). We further hypothesise that the greater release of GLP- 1 (thus, release of insulin) after RYGB over LAGB is related to the higher expression of small intestinal sweet taste receptors, leading to better glucose control and weight loss in these patients. This study, therefore, aims to evaluate the expression of small intestinal sweet taste receptors before and after a sugar ‘meal’ and its relationship to GLP-1 concentration, glucose control and body weight in morbidly obese subjects and patients who undergo RYGB and LAGB.
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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
41182
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Dr Nam Q Nguyen
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Address
41182
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Department of Gastroenterology and Hepatology, Q7 Level 7 North Wing Royal Adelaide Hospital North Terrace Adelaide SA 5000
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Country
41182
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Australia
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Phone
41182
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+61 8 8222 2412
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Fax
41182
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Email
41182
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quoc.nguyen@health.sa.gov.au
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Contact person for public queries
Name
41183
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Nam Q Nguyen
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Address
41183
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Department of Gastroenterology and Hepatology, Q7 Level 7 North Wing Royal Adelaide Hospital North Terrace Adelaide SA 5000
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Country
41183
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Australia
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Phone
41183
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+61 8 8222 2412
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Fax
41183
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Email
41183
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quoc.nguyen@health.sa.gov.au
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Contact person for scientific queries
Name
41184
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Nam Q Nguyen
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Address
41184
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Department of Gastroenterology and Hepatology, Q7 Level 7 North Wing Royal Adelaide Hospital North Terrace Adelaide SA 5000
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Country
41184
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Australia
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Phone
41184
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+61 8 8222 2412
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Fax
41184
0
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Email
41184
0
quoc.nguyen@health.sa.gov.au
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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.
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