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Trial registered on ANZCTR


Registration number
ACTRN12610000451000
Ethics application status
Approved
Date submitted
27/05/2010
Date registered
2/06/2010
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of bariatric surgery on gastrointestinal function.
Scientific title
Prospective evaluation of healthy volunteers and patients following Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB) and the effects on gastric emptying, small intestinal transit, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite, gastrointestinal symptoms, plasma lipids and body weight
Secondary ID [1] 251871 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257466 0
Condition category
Condition code
Oral and Gastrointestinal 257616 257616 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Effect of Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB) on gastric emptying, small intestinal transit, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite, gastrointestinal (GI) symptoms, plasma lipids and body weight.

Gastric emptying and small intestinal transit will be measured using scintigraphy
Gut hormones, glycaemia and plasma insulin will be measured by taking blood samples
Plasma lipid and glucose absorption measured using a 13C triolein breath test and 3-O-methyl-glucose (3-OMG) respectively.
Appetite and gastrointestinal symptoms will be measured using questionnaires.

This is a prospective longitudinal study in which all obese subjects will be studied on 4 occasions: 6-8 weeks before surgery (to avoid the pre-operative dietary restriction period), and at 1, 6 and 12 months after surgery; controls will be studied once. Each study will be 6hours in duration.

A group of 20 age- and gender- matched lean volunteers will serve as the “control group”, to provide “normal data” for which the results from the patients’ will be compared. The healthy subjects will only be studied once, with similar concurrent measurements of gastric emptying, gut hormones, blood glucose, blood pressure, heart rate and gastrointestinal symptoms as the surgical subjects.
Intervention code [1] 256556 0
Not applicable
Comparator / control treatment
Data comparison between bariatric surgery (banding vs. bypass) patient cohorts.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258526 0
The main aim of the current study is to determine and compare the impact of RYGB and LAGB on gastric emptying (GE) and small intestinal (SI) transit.
Timepoint [1] 258526 0
Physiological studies will be conducted on 4 occasions: 6-8 weeks before surgery (to avoid the pre-operative dietary restriction period), and at 1, 6 and 12 months after surgery. The rate of GE and SI transit will be measured using scintigraphy for the entire 6 hour duration of the study
Primary outcome [2] 258554 0
Determine and compare the impact of RYGB and LAGB on plasma concentration of gut hormones (Cholecystokinin peptide YY, ghrelin, glucagon-like peptide-1 and insulin)
Timepoint [2] 258554 0
Measured by taking blood samples every 15mins for the first 2 hours of the study and every 30mins for the following 2 hours of the study
Primary outcome [3] 258555 0
Determine and compare the impact of RYGB and LAGB on small intestinal glucose and lipid absorption
Timepoint [3] 258555 0
Three grams of 3-O-methyl-glucose (3-OMG) and 200 microlitres of triolein will be added to the test meal to assess small intestinal absorption of glucose and lipid. A 13C triolein breath test will be performed to assess small intestinal lipid absorption. End-expiratory breath samples will be collected at baseline and every 30 minutes postprandially for 6 hrs.
Secondary outcome [1] 264355 0
Determine and compare the impact of RYGB and LAGB on blood glucose concentration and the correlation to the rate of gastric emptying
Timepoint [1] 264355 0
Blood glucose concentrations will be immediately determined using a portable blood glucose meter every 15mins for the first 2 hours of the study and every 30mins of the study there after.
Secondary outcome [2] 264401 0
Determine and compare the impact of RYGB and LAGB on blood pressure (BP) and heart rate (HR) and the correlation to the rate of gastric emptying.
Timepoint [2] 264401 0
BP (systolic and diastolic) and HR will also be measured with an automated oscillometric BP monitor (DINAMAP ProCare 100) at 3min intervals for the first 2 hours of the study and every 10mins for the following 2 hours
Secondary outcome [3] 264402 0
Gastrointestinal symptoms and quality of life (QOL) will also be recorded in both RYGB and LAGB participants
Timepoint [3] 264402 0
Gastrointestinal symptoms and QOL will be measured on study days using questionnaires

Eligibility
Key inclusion criteria
Body Mass Index (BMI) =40kg/m2; or BMI of between 35kg/m2 and 40kg/m2 with other significant disease
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Medical history: respiratory, cardiovascular, hepatic and/or renal disease
- Chronic alcohol abuse
- epilepsy
- medication known to affect gastrointestinal function
- previous gastrointestinal surgrey (excluding obesity surgery)
- Patients with diabetes mellitus requiring oral hypoglycaemic medication and/or insulin
- exposure to ionising radiation for research purposes in past 12 months
- Females not using appropriate contraceptive method
- Pregnant/breast feeding mothers
- Smoking > 10 cigarettes / day

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/05/2010
Actual
10/06/2010
Date of last participant enrolment
Anticipated
Actual
10/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2932 0
5000

Funding & Sponsors
Funding source category [1] 257066 0
Government body
Name [1] 257066 0
National Health & Medical Research Council
Country [1] 257066 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256341 0
None
Name [1] 256341 0
Address [1] 256341 0
Country [1] 256341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259090 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259090 0
Ethics committee country [1] 259090 0
Australia
Date submitted for ethics approval [1] 259090 0
Approval date [1] 259090 0
16/04/2010
Ethics approval number [1] 259090 0
091124

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

Contacts
Principal investigator
Name 31225 0
A/Prof Nam Nguyen
Address 31225 0
Department of Gastroenterology
Royal Adelaide Hospital
North Terrace, Adelaide SA 5000
Country 31225 0
Australia
Phone 31225 0
+61422113598
Fax 31225 0
Email 31225 0
Quocnam.nguyen@sa.gov.au
Contact person for public queries
Name 14472 0
Jenna Burgess
Address 14472 0
Q7 Motility Laboratory
Department Gastroenterology & Hepatology
Level 7, North Wing
North Terrace
Adelaide SA 5000
Country 14472 0
Australia
Phone 14472 0
+61 8 8222 5214
Fax 14472 0
+61 8 8222 5885
Email 14472 0
jenna.bambrick@sa.gov.au
Contact person for scientific queries
Name 5400 0
Nam Nguyen
Address 5400 0
Q7 Motility Laboratory
Department Gastroenterology & Hepatology
Level 7, North Wing
North Terrace
Adelaide SA 5000
Country 5400 0
Australia
Phone 5400 0
+61422113598
Fax 5400 0
+61 8 8222 5885
Email 5400 0
quocnam.nguyen@sa.gov.au

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
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Documents added automatically
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