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Trial registered on ANZCTR


Trial ID
ACTRN12613000718741
Ethics application status
Approved
Date submitted
27/06/2013
Date registered
1/07/2013
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of fat and protein ‘pre-loads’ on Gastric Emptying, Small Intestine transit, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite and Gastrointestinal symptoms in response to a mixed meal after Roux-en-Y Gastric Bypass
Scientific title
Effects of fat and protein ‘pre-loads’ on GE, SI transit, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite and GI symptoms in response to a mixed meal after RYGB
Secondary ID [1] 282727 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity and RYGB surgery 289457 0
Condition category
Condition code
Diet and Nutrition 289773 289773 0 0
Obesity
Surgery 289833 289833 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty morbidly obese subjects will be studied on 3 occasions, which are separated by at least 4 weeks. The subjects will be randomised into 3 “pre-load” groups, in which they will consume either a control of 30ml of water, or one of two preloads, either 30ml olive oil, or 55g Whey protein (in 100ml soup), 30min before a 50g beef patty meal. the preload is administered at t= -30min and the beef patty at t=0
Intervention code [1] 287390 0
Treatment: Other
Comparator / control treatment
The control will be consuming 30mL of water before the 50g beef patty meal
Control group
Placebo

Outcomes
Primary outcome [1] 289877 0
Rate of gastric emptying and small intestinal transit as measured by a Gamma camera that will measure the rate at which the stomach empties a 50 or 200ml glucose drink containing 3g of glucose (3-ortho-methyl-D-gluco-pyranose) and a small amount of radiation (which can be detected by the camera)
Timepoint [1] 289877 0
Gastric emptying curves (expressed as % of the maximum content of the total stomach) will be derived and the content of the total stomach at t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210 and 240 mins calculated. The 50% emptying time (T50) will also be obtained.
Primary outcome [2] 289878 0
Plasma concentration of gut hormones (CCK, PYY, ghrelin, GLP-1 and insulin)
Timepoint [2] 289878 0
Blood samples (approximately 15 ml) will be taken prior (t = -2 mins) to the ingestion of the drink and then at t = 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 mins
Primary outcome [3] 289879 0
Small intestinal glucose and lipid absorption as measured by a 13C triolein breath test
Timepoint [3] 289879 0
End-expiratory breath samples will be collected at baseline and every 30 minutes postprandially for 6 hrs.
Secondary outcome [1] 303462 0
Blood glucose concentration and the correlation to the rate of gastric emptying, as measured by a portable blood glucose meter.
Timepoint [1] 303462 0
Measured at (t = -2 mins) to the ingestion of the drink and then at t = 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 mins
Secondary outcome [2] 303463 0
Blood pressure and heart rate and the correlation to the rate of gastric emptying, measured with an automated oscillometric BP monitor (DINAMAP ProCare 100)
Timepoint [2] 303463 0
~3min intervals for the first 2 hours and after that every 10mins for the next 2 hours
Secondary outcome [3] 303464 0
Gastrointestinal symptoms before and during procedure, as measured by a validated visual analogue scales (VAS) and also by a validated 19-point GI symptom questionnaire
Timepoint [3] 303464 0
VAS is completed at Baseline and then at and then at t = 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 mins
The validated 19-point GI symptom questionnaire is completed by patient before the procedure on each visit.
Secondary outcome [4] 303467 0
Patient body weight using calibrated mecahnical scales
Timepoint [4] 303467 0
Measured on each visit before the procedure
Secondary outcome [5] 303468 0
The impacts of pre-loads on patients with and without a history of diabetes mellitus
Timepoint [5] 303468 0
This will be assessed once all data collection is complete.

Eligibility
Key inclusion criteria
Subjects who have had have had RYGB (Roux-en-Y Gastric Bypass)
RYGB was performed for at least 6 months ago
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history)
Subjects requiring medication that may influence gastrointestinal function
No previous history of surgery to the gastrointestinal tract apart from the RYGB or LAGB
Subjects who have been exposed to ionising radiation for research purposes in the past 12 months
Female patients not using appropriate contraceptive method (ie oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device (IUD), Norplant method)
Pregnancy and/or breastfeeding mothers
Smoking > 10 cigarettes/day
Alcohol consumption > 20 g/day

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
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)
SA
Recruitment hospital [1] 1173 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7020 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287518 0
Government body
Name [1] 287518 0
Australian Government National Health and Medical Research Council
Address [1] 287518 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 287518 0
Australia
Funding source category [2] 287519 0
Hospital
Name [2] 287519 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
Address [2] 287519 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, North Wing Motility Laboratory Q7, Level 7, North Terrace, Adelaide, SA, 5000
Country [2] 287519 0
Australia
Primary sponsor type
Individual
Name
Nam Nguyen
Address
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, North Wing Motility Laboratory Q7, Level 7, North Terrace, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 286264 0
Hospital
Name [1] 286264 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
Address [1] 286264 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, North Wing Motility Laboratory Q7, Level 7, North Terrace, Adelaide, SA, 5000
Country [1] 286264 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289496 0
Royal Adelaide Hospital Reserach Ethics Comittee
Ethics committee address [1] 289496 0
The Royal Adelaide Hospital Research Ethics Committee

Level 3, Hanson Institute IMVS Building

North Terrace

Adelaide SA 5000

Ethics committee country [1] 289496 0
Australia
Date submitted for ethics approval [1] 289496 0
Approval date [1] 289496 0
25/08/2010
Ethics approval number [1] 289496 0
100808

Summary
Brief summary
The current study aims to examine the effects of protein and fat ‘preloads’ of RYGB on GE or SI transit, appetite-related and incretin hormones, GI symptoms and haemodynamics. We hypothesized that when given before a mixed meal, (A) a fat ‘preload’ has no effect on GE but slows SI transit, increases the GLP-1 and PYY responses, reduces glycaemic and insulin responses and attenuates the fall in BP and rises in HR/SMA blood flow, as well as symptoms; and (B) a protein ‘preload’ has no effect on GE but slows SI transit, increases GLP-1 and PYY responses, reduces the glycaemic but increases the insulin response and attenuates the fall in BP and rises in HR/SMA flow and symptoms.
Trial website
Trial related presentations / publications
Article: Effects of Fat and Protein Preloads on Pouch Emptying, Intestinal Transit, Glycaemia, Gut Hormones, Glucose Absorption, Blood Pressure and Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass
Nam Q Nguyen · Tamara L Debreceni · Carly M Burgstad · Melissa Neo · Max Bellon · Judith M Wishart · Scott Standfield · Dylan Bartholomeusz · Chris K Rayner · Gary Wittert · Michael Horowitz.
Obesity Surgery 05/2015; DOI:10.1007/s11695-015-1722-7
Public notes

Contacts
Principal investigator
Name 41010 0
Dr Nam Q Nguyen
Address 41010 0
Department of Gastroenterology & Hepatology, North Wing Level 7 Q7, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 41010 0
Australia
Phone 41010 0
+61 8 8222 2412
Fax 41010 0
Email 41010 0
quoc.nguyen@health.sa.gov.au
Contact person for public queries
Name 41011 0
Dr Nam Q Nguyen
Address 41011 0
Department of Gastroenterology & Hepatology, North Wing Level 7 Q7, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 41011 0
Australia
Phone 41011 0
+61 8 8222 2412
Fax 41011 0
Email 41011 0
quoc.nguyen@health.sa.gov.au
Contact person for scientific queries
Name 41012 0
Dr Nam Q Nguyen
Address 41012 0
Department of Gastroenterology & Hepatology, North Wing Level 7 Q7, Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
Country 41012 0
Australia
Phone 41012 0
+61 8 8222 2412
Fax 41012 0
Email 41012 0
quoc.nguyen@health.sa.gov.au