Active — Not RecruitingNot Applicable

4XL Study - Obesity Surgery in Adolescence

Norway120 participantsStarted 2009-06

Plain-language summary

The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

Who can participate

Age range13 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 13 and 18 years of age at inclusion * Tanner stage 4-5 * BMI \> 40 kg/m2 or BMI \> 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor) * At least one year multidisciplinary treatment completed Exclusion Criteria: * Tanner stage \< 4 * Substantial risk for lack of compliance * Obesity syndrome (e.g., Prader Willi syndrome) * Obesity related to brain damage * Serious general disease * Monogenic obesity

What they're measuring

BMI and weight loss

Timeframe: Baseline, Year 1, 2, 5, 10

Trial details

NCT IDNCT00923819

SponsorSykehuset i Vestfold HF

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-08

View on ClinicalTrials.gov More Obesity, Morbid trials