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
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
Bond University
150 participants
Sep 30, 2020
Observational
Conditions
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
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria5
- 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
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Interventions
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.
Locations(1)
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ACTRN12620000251921