Obese adolescents in randomized control trial of the intragastric balloon and lifestyle intervention combination versus lifestyle intervention alone in reducing weight and associated health risks.

Dr Elizabeth Davis0 个研究点目标入组 50 人开始时间: 2009年11月19日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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

发起方

Dr Elizabeth Davis