Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000251921
Ethics application status
Approved
Date submitted
12/02/2020
Date registered
26/02/2020
Date last updated
1/02/2023
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Bariatric Body Composition Study: A prospective cohort study comparing post-procedural body composition and bone density changes via dual-energy X-ray absorptiometry (DXA) for patients electing bariatric surgery in Australia
Scientific title
Bariatric Body Composition (BBC) Study: The use of dual-energy X-ray absorptiometry scans for bone mineral density and body composition assessment and to compare changes relative to weight loss over 12-months in patients electing bariatric surgery in Australia
Secondary ID [1] 300530 0
Nil known
Universal Trial Number (UTN)
U1111-1248-1466
Trial acronym
BBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 316236 0
osteoporosis 316237 0
micronutrient deficiencies 316238 0
Condition category
Condition code
Diet and Nutrition 314523 314523 0 0
Obesity
Surgery 314527 314527 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants in this study will have consented to one of the following procedures at Weight Loss Solutions Australia; Laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), Endoscopic sleeve gastroplasty, 6-month Orbera intragastric balloon and 2-month Spatz3 adjustable intragastric balloon. All of which, will be performed as per standard practice by one of the WLSA surgeons.

Study Procedures:
Laparoscopic sleeve gastrectomy - patients are placed under general anaesthesia for the procedure and local anaesthetic is administered at all local trocar entrance sites. The abdominal cavity is accessed via a supraumbilical incision and using a trocar. Two staplers are used commencing at the pylorus up to the incisura angularis. The staple-line is inverted resulting in a gastric sleeve

Roux-en-Y gastric bypass - Patients are placed under general anaesthesia for the procedure. The procedure is usually performed laparoscopically. The stomach is divided horizontally leaving a small upper section and a larger lower section which is stitched shut. The smaller upper section, or pouch, to the small intestine “bypassing” the majority of the stomach, duodenum, and some or all of the jejunum.

Endoscopic sleeve gastroplasty - Patients are placed under general anaesthesia for the procedure. A cap-based flexible endoscopic suturing system (OverStitch; Apollo Endosurgery, Austin, TX) is used to perform the procedure. The ESG is created by placing full thickness sutures from the incisura angularis to the proximal gastric body to mould the gastric lumen into a tubular configuration.

6-month Orbera intragastric balloon - Patients are placed under general anaesthesia for the procedure. The IGB are placed endoscopically in the stomach and then inflated with saline to a volume individualised to the patient. Typical volumes are between 400 and 700ml.

12-month Spatz3 adjustable intragastric balloon - Patients are placed under general anaesthesia for the procedure. The IGB are placed endoscopically in the stomach and then inflated with saline to a volume individualised to the patient; which may then be adjusted at a later date. Typical volumes are between 350ml and 500ml initially, with adjustments up to approximately 500ml to 750ml.

Participants will be required to provide informed consent to partake in the study.
If they agree to participate they will;
1. Be asked to visit Bond Institute of Health and Sport (Robina, Qld) for approximately 1-hour before the bariatric procedure and 6- and 12-months after the procedure to:
a. Receive three DXA scans (right side body composition, left side body composition, and bone mineral density of hip).
b. Complete some questionnaires which will ask basic information about them and their life, health and medical status, quality of life, and any gastrointestinal or other symptoms or side-effects of the procedure.
c. Have their blood pressure, weight, and height measured.

2. Agree for the research team to access medical records (at WLSA and/or letters/records from your General Practitioner or other specialists) to record data related to the procedure, such as blood pathology, medications, and weight, as well as their contact details.

3. Have the results of the body composition DXA scan emailed to them and added to their WLSA medical record.

4. Have the results of the bone mineral density scan sent to their usual GP if the researchers identify any need for follow-up medical care.
Intervention code [1] 316832 0
Not applicable
Comparator / control treatment
Patients at Weight Loss Solutions Australia (WLSA) outside of this study will receive usual care. Usual care does not involve DXA scans. WLSA offer bariatric procedures alongside 12-months of compulsory multidisciplinary lifestyle intervention and follow-up.
Control group
Active

Outcomes
Primary outcome [1] 322845 0
Phase I: Recruitment rate
Instrument: Process evaluation through study data
Timepoint [1] 322845 0
Baseline
Primary outcome [2] 322846 0
Phase II: 6-months retention rate
Instrument: Process evaluation through study data
Timepoint [2] 322846 0
T1 (6-months post-procedure)
Primary outcome [3] 322847 0
Phase III: Android fat mass, g (%),
Instrument: DXA
Timepoint [3] 322847 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure, primary endpoint)
Secondary outcome [1] 379999 0
Adverse events (via Post-procedure survey)
Survey designed specifically for this study.
Adverse events can be surgically or medically related, nutrient related or gastrointestinal related and range in severity from mild, moderate to serve. The event may be related to the surgery directly, possibly related or not directly related. Common adverse events include nutritional deficiencies and surgical events (eg needing to return for a diagnostic laparoscopy for pain or washout, washout and debridement of infected umbilical hernia repair, repair small bowel)
Timepoint [1] 379999 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [2] 380000 0
Excess weight, kg (via Scales)
Timepoint [2] 380000 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [3] 380001 0
Bone mineral content, kg (via DXA)
Timepoint [3] 380001 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [4] 380002 0
Body mass index, kg/m2 (via Scales and stadiometer: medical records)
Timepoint [4] 380002 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [5] 380003 0
Fasting serum biochemistry (via Fasting blood sample: WLSA medical records)
Timepoint [5] 380003 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [6] 380004 0
Diet quality and nutrient intake (via 24hr dietary recall)
Timepoint [6] 380004 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [7] 380005 0
Quality of life (via EQ-5D-5L)
Timepoint [7] 380005 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [8] 380006 0
Gastrointestinal symptoms (via GSRS 7-item scale)
Timepoint [8] 380006 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [9] 380007 0
Systolic and diastolic blood pressure (via Electronic sphygmomanometer)
Timepoint [9] 380007 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [10] 380008 0
Total body weight, kg (via scales)
Timepoint [10] 380008 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [11] 380009 0
Total body fat mass, kg (via DXA)
Timepoint [11] 380009 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [12] 380010 0
Total body lean mass, kg (via DXA)
Timepoint [12] 380010 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [13] 380011 0
Android/gynoid fat mass ratio (via DXA)
Timepoint [13] 380011 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [14] 380411 0
THIS IS A PRIMARY OUTCOME
Neck of femur g/cm2 (via DXA)
Timepoint [14] 380411 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure, primary endpoint)
Secondary outcome [15] 380412 0
Medical outcome (via Post-procedure survey)
Survey designed specifically for this study
Timepoint [15] 380412 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)
Secondary outcome [16] 380413 0
Supplement use (via Post-procedure survey)
Survey designed specifically for this study.
Timepoint [16] 380413 0
T0 (Baseline)
T1 (6-months post-procedure)
T2 (12-months post-procedure)

Eligibility
Key inclusion criteria
The following inclusion criteria will apply:
• Consented to LSG, RYGB, ESG, or IGB procedure at WLSA
• Confirmed procedure via payment to WLSA
• Aged equal or greater than 18 years
• Able to provide written informed consent
• Willing to physically attend Bond Institute of Health and Sport (BIHS), Robina, for data collection at 3 timepoints.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will apply:
• Unable to be followed-up at 6- and/or 12-months (e.g. planning to relocate, etc)
• Weigh more than 160 kg (Lunar Prodigy weight limit)
• Any condition that precludes safe operation and proper positioning of patients
• Pregnancy (also contraindication of bariatric procedure)
• Within the week after other radiological investigations using contrast media

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participant, procedure, and outcomes will be reported using descriptive statistics, and differences between groups at baseline will be tested for using chi-square for categorical variables or students t-test (or non-parametric equivalent if required) for continuous variables. Changes within each group for the primary and secondary outcomes from baseline to 6-month and 12-month follow-up will be tested using linear mixed models. Secondary outcomes at 6-months and 12-months will be tested for significant differences between procedure types using multiple regression to account for confounding variables. Support from the Bond University HSM statistician will be sought to account for missing data and conduct adjusted linear mixed models for the primary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
30/09/2020
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
150
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304939 0
Commercial sector/Industry
Name [1] 304939 0
Weight Loss Solutions Australia
Country [1] 304939 0
Australia
Primary sponsor type
University
Name
Bond University
Address
University Drive,
Robina,
4226, Qld
Country
Australia
Secondary sponsor category [1] 305294 0
None
Name [1] 305294 0
Address [1] 305294 0
Country [1] 305294 0
Other collaborator category [1] 281190 0
Commercial sector/Industry
Name [1] 281190 0
Weight Loss Solutions Australia
Address [1] 281190 0
Suite 3, Podium Level
Lakeside 1, 1 Lake Orr Drive
Varsity Lakes
QLD 4227
Country [1] 281190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305353 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 305353 0
Research Services
Building 1C, Level 4
Bond University QLD 4229
Ethics committee country [1] 305353 0
Australia
Date submitted for ethics approval [1] 305353 0
24/02/2020
Approval date [1] 305353 0
14/04/2020
Ethics approval number [1] 305353 0
CM03411

Summary
Brief summary
No study has compared post-procedural body composition and bone density changes via dual-energy X-ray absorptiometry (DXA) for patients electing bariatric surgery in Australia.
This prospective cohort study, aims to: 1) test the feasibility and acceptability of conducting bone mineral density and body composition assessment via DXA scan at pre-procedure, 6-months and 12-months post-procedure; and 2) compare bone mineral density and body composition changes relative to weight loss over 12-months. It is hypothesised that loss of bone mineral density will be evident by 12-months post-procedure, particularly in females and that both fat mass and lean mass will reduce over the 12-months post-procedure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100086 0
Dr Skye Marshall
Address 100086 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 100086 0
Australia
Phone 100086 0
+61 07 5595 4410
Fax 100086 0
Email 100086 0
[email protected]
Contact person for public queries
Name 100087 0
Dr Skye Marshall
Address 100087 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 100087 0
Australia
Phone 100087 0
+61 07 5595 4410
Fax 100087 0
Email 100087 0
[email protected]
Contact person for scientific queries
Name 100088 0
Dr Skye Marshall
Address 100088 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 100088 0
Australia
Phone 100088 0
+61 07 5595 4410
Fax 100088 0
Email 100088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study does not have ethical approval to share data


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.