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Trial registered on ANZCTR


Registration number
ACTRN12619000982112
Ethics application status
Approved
Date submitted
5/06/2019
Date registered
10/07/2019
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Weight loss outcomes in obese patients undergoing Laparoscopic Sleeve Gastrectomy
Scientific title
Understanding weight loss outcomes in obese patients undergoing laparoscopic sleeve gastrectomy at Gold Coast Private Hospital (Study Two)
Secondary ID [1] 298240 0
Nil Known
Universal Trial Number (UTN)
U1111-1233-4504
Trial acronym
LSG-SWLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 313086 0
Diabetes 313087 0
Condition category
Condition code
Surgery 311572 311572 0 0
Surgical techniques
Diet and Nutrition 311653 311653 0 0
Obesity
Mental Health 311691 311691 0 0
Eating disorders
Metabolic and Endocrine 311692 311692 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an observational cohort study of weight loss outcomes in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) procedure at the Gold Coast Private Hospital.
Participants will undertake baseline testing approximately 4 weeks prior to their scheduled LSG procedure. This data will represent the patients baseline before weight loss. Two weeks prior to the LSG procedure, all participants (regardless of their involvement in the present study) will begin a pre-operative weight loss intervention as required by Dr Victor Liew. This period involves a very low calorie diet (VLCD) which helps patients lose visceral fat and reduce the size of the fatty liver, making surgery safer and often leads to a better surgical outcome. A second baseline analysis will occur approximately one week prior to the LSG procedure, to account for any changes which may have occurred between baseline testing and the VLCD. Three months post-LSG procedure, participants will undergo all testing, as they did at baseline. These tests will be repeated at 6, 12, 24 months post-operative and each year up to 5 years post-surgery. The information gained on percentage of weight loss during the initial 2-3 months post-surgery will inform the research team as to which participants are high or low responders (known as the responder identification period). We will use retrospective data from previous patients who underwent LSG by same surgical team in 2017-2018 to generate weight loss patterns. We will use these patterns to estimate weight loss outcomes of patients and selection for low and high responders to LSG early post-surgery. All participants that are within the top or bottom 10th percentile for percentage of total weight loss will be invited to continue with comprehensive testing and tissue biopsies at the 6, 12 and 24 month post-operative point, and every year thereafter for up to 5 years. All other participants will continue to track weight, changes in medication use, blood pathology for characterisation of presence or absence/resolution of comorbidities (impaired glucose tolerance, diabetes, dyslipidemia, hypertension).
Intervention code [1] 314639 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320282 0
Body weight
Changes in body weight will be monitored across the trial and recorded at time of surgery on digital medical grade scales and self-reported by online website using digital home scales post-surgery.
Timepoint [1] 320282 0
Before surgery and 1, 2, 3, 4, 5, 6, 12, 24 (primary end point) months and yearly up to 5 years post-surgery.
Primary outcome [2] 320520 0
Body mass index (BMI; kg/m2)
Composite of height and weight
Changes in BMI will be monitored across the trial by self reporting of body weight using digital home scales. For all participants, height used to calculate BMI will be from that measured at time of surgery using a stadiometer.
Timepoint [2] 320520 0
Before surgery and 1, 2, 3, 4, 5, 6, 12, 24 (primary end point) months and yearly up to 5 years post-surgery.
Secondary outcome [1] 371347 0
Nutritional profile (energy intake, vitamin levels) will be assessed
24 diet recalls (Multi-pass) and analysed by Foodworks software. Composite outcome measure.
Timepoint [1] 371347 0
Before surgery and 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [2] 371680 0
Eating behaviour
Eating behaviour will be assessed using validated Questionnaires (Eating behavior- Three Factor Eating Questionnaire (TFEQ), Loss of Control over Eating Scale (LOCES) (eating inventory part 1 and 2), Dutch Eating behavior questionnaire. Composite outcome measure.
Timepoint [2] 371680 0
Before surgery and 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [3] 371681 0
Psychology
will be assessed across up to 9 psyche domains including stress, anxiety and depression using validated survey including SA45, CES-Depression, DASS21. Composite outcome measure.
Timepoint [3] 371681 0
Before surgery and 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [4] 371682 0
Sleep quality
Sleep quality will be assessed using self-reported validated questionnaires Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index. Composite outcome measure.
Timepoint [4] 371682 0
Before surgery and 6, 12, 24 months post-surgery
Secondary outcome [5] 371683 0
Quality of life
Quality of life will be assessed by validated questionnaires SF-36 Health survey, and Quality of Life Scale (QOLS). Composite outcome measure.
Timepoint [5] 371683 0
Before surgery and 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [6] 371684 0
Resting Metabolic Rate (RMR)
will be assessed by indirect calorimetry using ParvoMedics at Bond Institute of Health and Sport
Timepoint [6] 371684 0
Before surgery and for select participants (high and low responders) at 3, 6, 12 and 24 months post-surgery.
Secondary outcome [7] 371687 0
Genetic traits
Genetic traits (new and previously identified SNPs associated with obesity) will be identified by performing GWAS of DNA extracted from whole blood specimen.
This is an exploratory outcome
Timepoint [7] 371687 0
Before surgery as these will not change
Secondary outcome [8] 371688 0
Physiological traits will be assessed by analyses of plasma and adipose and skeletal muscle tissue biopsies.

This is an exploratory outcome
Timepoint [8] 371688 0
Before surgery and for select participants (high and low responders) at 3-6 months post-surgery.
Secondary outcome [9] 371689 0
Clinical traits- blood pathology (composite outcome)
will be assessed by laboratory assessments of serum and plasma and include complete blood cell count and ferritin, albumin, fasting glucose, fasting insulin, glycated hemoglobin, lipid profile, serum folate, vitamin B12, vitamin D, and parathyroid hormone analyses.
Timepoint [9] 371689 0
Before surgery, 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [10] 371692 0
Anthropometric measures (composite outcome)
Anthropometric measures will be include measurement of Waist (narrow-point), umbilicus (midpoint), hip circumference.
Measurements will be taken to the nearest 0.1 cm, directly on skin, using a narrow, flexible and inelastic steel tape (Lufkin W606PM, Apex Tool Group, North Carolina, USA). Participants were dressed in leggings and a sports bra or underwear. At each measurement site, two measurements were taken, and if the difference between the measurements was >1 cm, a third measurement was taken. The average of each of the two measurements at each site (or the average of the two closest measurements if a third measurement was taken) will be recorded as the result.
Timepoint [10] 371692 0
Before surgery all participants and for select participants (high and low responders) 3, 6, 12, 24 months post-surgery
Secondary outcome [11] 372012 0
Cardiovascular disease (CVD) risk
will be determined by serum/ plasma cholesterols (total and HDL) by commercial pathology lab, blood pressure by automated medical grade monitor (hospital and GP), diabetes status (fasting glucose, insulin and HbA1c), smoking status, age, gender; and using CVD risk calculator www.cvdcheck.org.au/calculator/
Timepoint [11] 372012 0
time of surgery and 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [12] 372013 0
Blood pressure
Blood pressure will be measured by automated blood pressure machine at the hospital and followup doctors clinic, it will be measured 3 times and average of the 3 will be used.
Timepoint [12] 372013 0
time of surgery and 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [13] 372014 0
Diabetes status
Diabetes defined as fasting glucose level higher than 126 mg/dL (to convert to millimoles per liter, multiply by 0.0555) and glycated hemoglobin greater than 6% of total hemoglobin (to convert to proportion of total hemoglobin, multiply by 0.01), or any levels in a patient receiving antihyperglycemic treatment. Impaired fasting glucose (IFG) defined as a fasting glucose level higher than 100 mg/dL and lower than 126 mg/dL in patients with no use of antihyperglycemic treatment.

Status will be assessed by blood pathology results of fasting glucose, fasting insulin, glycated hemoglobin) assessed by analysis of plasma and serum samples using standard methods by commercial blood pathology organization, patient records and self reporting of medication use by online website.
Improvements:
Significant improvement in HbA1C and fasting blood glucose when insulin/oral diabetic medication is discontinued or when the dose of the medication is halved
Partial remission:
Return to pre-diabetic hyperglycaemia (HbA1C 6 to 6.4%, fasting blood glucose 100-125 mg/dL) in the absence of medications
Complete remission:
Normal glucose (HbA1C <6%, fasting blood glucose <100mg/dL) in the absence of medications
Timepoint [13] 372014 0
Before surgery, 3, 6, 12, 24 months post-surgery and every year up to 5 years.
Secondary outcome [14] 372015 0
Hypertension status
Hypertension defined as blood pressure higher than 140/90 mm Hg on more than 3 occasions or the use of medications to treat hypertension.
Status will be assessed by automated blood pressure (GP/hospital), patient records and self reporting of medication use by online website.
Improvements:
Decreased in dosage of blood pressure medication or decrease in systolic or diastolic blood pressure on the same medications.
Partial remission:
Return to pre-hypertension values when off all medications (120-140/80-89).
Complete remission:
Normal blood pressure (BP <120/80) when off all medications.
Timepoint [14] 372015 0
time of surgery and 3, 6, 12, 24 months and upto 5 years post-surgery
Secondary outcome [15] 372016 0
Hypercholesterolemia status
defined as a total cholesterol level higher than 200 mg/dL (to convert to millimoles per liter, multiply by 0.0259) will be assess by measuring levels in serum/plasma by commercial pathology lab.
Status will be assessed by blood pathology results of cholesterols assessed by analysis of plasma/ serum samples using standard methods by commercial blood pathology organization, patient records and self reporting of medication use by online website.
Improvement:
Decrease in the number of pills or dose of the anti lipid medications or improved control of lipids on equivalent medications
Complete remission:
Normal lipid levels off medications
Timepoint [15] 372016 0
time of surgery and 3, 6, 12, 24 months and upto 5 years post-surgery
Secondary outcome [16] 372017 0
Hypertriglyceridemia status
defined as a triglyceride level higher than 150 mg/dL (to convert to millimoles per liter, multiply by 0.0113) will be assess by measuring levels in serum/plasma by commercial pathology lab
Status will be assessed by blood pathology results of triglycerides assessed by analysis of plasma/ serum samples using standard methods by commercial blood pathology organization, patient records and self reporting of medication use by online website.
Improvement:
Decrease in the number of pills or dose of the anti lipid medications or improved control of lipids on equivalent medications
Complete remission:
Normal lipid levels off medications
Timepoint [16] 372017 0
time of surgery and 3, 6, 12, 24 months and upto 5 years post-surgery
Secondary outcome [17] 372244 0
Nutritional profile (macronutrient composition and vitamin levels) will be assessed
24 diet recalls (Multi-pass) and analysed by Foodworks software. Vitamin B12, Vitamin D and iron/ ferritin levels will be assessed by analyses of serum and plasma by commercial pathology laboratory. Composite outcome measure.
Timepoint [17] 372244 0
Before surgery and 3, 6, 12, 24 months post-surgery and every year up to 5 years.

Eligibility
Key inclusion criteria
Considered Obese (BMI >35 kg/m2).
Scheduled to have laparoscopic sleeve gastrectomy (LSG) performed by Dr Victor Liew at the Gold Coast Private Hospital within the next six months
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-Caucasian
Previously undergone bariatric surgery procedure
Not willing to commit to pre- and post-operative testing at Bond University.
Type 1 diabetes

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Up to N= 200 participants will be recruited into the study involving comprehensive testing. This number will account for dropouts and incomplete/ missing data sets.
Ideally, we will have N=80 in top and bottom percentile groups, accounting for 20-30% dropout rate we will require 200 participants for this study.
Up to N= 800 participants will be recruited into the study for less comprehensive testing (between upper and lower 10th percentiles), accounting for 20-30% dropout rate in the first 24months and greater beyond, we will require 1000 participants for this study (at baseline) Likely less than 10% will have followup data at 5yr post-surgery.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13897 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 26670 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 302778 0
University
Name [1] 302778 0
Bond University
Country [1] 302778 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 302901 0
None
Name [1] 302901 0
Address [1] 302901 0
Country [1] 302901 0
Other collaborator category [1] 280726 0
Hospital
Name [1] 280726 0
Gold Coast Private Hospital
Address [1] 280726 0
14 Hill Street, Southport, 4215, QLD
Country [1] 280726 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303374 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 303374 0
Ethics committee country [1] 303374 0
Australia
Date submitted for ethics approval [1] 303374 0
Approval date [1] 303374 0
01/05/2019
Ethics approval number [1] 303374 0
HO01003

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

Contacts
Principal investigator
Name 93446 0
Dr Hayley O'Neill
Address 93446 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226, QLD
Country 93446 0
Australia
Phone 93446 0
+61 07 5595 0178
Fax 93446 0
Email 93446 0
haoneill@bond.edu.au
Contact person for public queries
Name 93447 0
Hayley O'Neill
Address 93447 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226, QLD
Country 93447 0
Australia
Phone 93447 0
+61 07 5595 0178
Fax 93447 0
Email 93447 0
haoneill@bond.edu.au
Contact person for scientific queries
Name 93448 0
Hayley O'Neill
Address 93448 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226, QLD
Country 93448 0
Australia
Phone 93448 0
+61 07 5595 0178
Fax 93448 0
Email 93448 0
haoneill@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.