Randomised Controlled Trial of the Bioenterics Intragastric Balloon (BIB) Versus Lifestyle Intervention Alone on Weight Loss and Reversal of Weight Related Diseases in Obese Adolescents.

Recruiting

• Conditions: Obesity in adolescents, and obesity-related comorbidities; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12609001004257
• Lead Sponsor: Dr Elizabeth Davis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adiposity: Body mass index (BMI) raw score and Z score will be used as indicators of total adiposity.[Assessed at baseline, 6 and 18 months.]