None listed
Conditions
Brief summary
The purpose of the study is to determine if an intra-gastric balloon in combination with a lifestyle program has a benefit for obese adolescents, compared to a lifestyle program alone.
Interventions
Participants randomised to the lifestyle intervention plus BIB will receive a Bioenterics Intragastric Balloon (BIB) for a duration of six months. The BIB is a smooth silicone, saline filled temporary device placed in the stomach. Participants will be admitted under the gastroenterology team at Princess Margaret Hospital (PMH) for 3 days duration for insertion. Both insertion and removal procedures involve a short general anaesthetic followed by inspection of the stomach and duodenum using an en
Participants randomised to the lifestyle intervention plus BIB will receive a Bioenterics Intragastric Balloon (BIB) for a duration of six months. The BIB is a smooth silicone, saline filled temporary device placed in the stomach. Participants will be admitted under the gastroenterology team at Princess Margaret Hospital (PMH) for 3 days duration for insertion. Both insertion and removal procedures involve a short general anaesthetic followed by inspection of the stomach and duodenum using an endoscope. The balloon device is inserted into the stomach; the balloon is inflated with saline and methylene blue and then disconnected. The insertion equipment is withdrawn. A detailed post operative dietary plan has been developed to slowly wean participants from liquid diet back to solids. A liquid vitamin and mineral supplement will be taken for the first week until the participant is back on a nutritionally balanced diet. Participants will have an individualized nutrition plan drawn up based on Australian dietary guidelines for children and adolescents. Removal of the balloon will occur after 6 months duration.
Sponsors
Dr Elizabeth Davis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Participants must fulfil the following criteria: 1. Living in metropolitan Perth and willing to attend outpatient appointments. 2. No significant weight loss despite = 3 months attempted lifestyle improvements. Participants must have a BMI Z-score >+3 OR a BMI Z-score>+2 AND 2 or more of the following co-morbidities. 1. Hyperlipidaemia 2. Impaired glucose tolerance/hyperinsulinaemia 3. Hepatitis steatosis 4. Hypertension, 5. Polycystic ovarian syndrome 6. Obstructive sleep apnoea 7. Benign intracranial hypertension 8. Degenerative joint disease.
Exclusion criteria
1. Previous gastrointestinal resections 2. Structural abnormalities of the gastrointestinal tract. 3. Psychiatric/eating disorder 4. Rural dwelling, 5. Active oesophagitis (Grade1) / active gastric ulcer or its previous complications/hiatus hernia (>5cm) 6. Pregnancy 7. Type 2 diabetes 8. Patient on anticoagulants or non-steroidal anti-inflammatory drugs gastric irritants, unwilling to make lifestyles changes or attend regular clinic appointments. 9. Unwilling to accept the probability of nausea and vomiting in the postoperative period. 10. Physical inability to maintain regular follow-up 11. Obstructive sleep apnoea requiring a continuous positive airway pressure (CPAP) machine
Outcome results
None listed