Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01172899 : Bariatric Surgery in Children.
PhasePhase 2
AgesMin: 12 Years Max: 16 Years
Eligibility
Inclusion Criteria:

- Aged 12 to 16

- Age and sex adjusted BMI >40 kg/m2 or >35 kg/m2 with associated co-morbidity.

* Associated co-morbidity includes: glucose intolerance, type 2 diabetes,
hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea
syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.

- > 1 year multidisciplinary organized weight reducing attempts with less than 5%
weight loss

- Demonstrate decisional capacity

Exclusion Criteria:

- Psychologically not suitable

- Pre-menarche or bone age <15 years in boys

- Obesity associated to other disorders such as hypothyroidism

- Syndromal disorders such as Prader-Willi syndrome

- Severe cardiorespiratory impairment (ASA class 3 or higher)

- Insufficiently fluid in the Dutch language

- Unwillingness to adhere to follow-up programmes
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01172899      |      Link to official Clinicaltrials.gov listing
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