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 sites50 target enrollmentNovember 19, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 19, 2009

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Dr Elizabeth Davis

•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

•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