TrialGlobe

Clinical trial

Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02378259

Active, not recruitingNot applicableInterventional

What this study is about

Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes. This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age13 Years to 16 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Diabetes, Hypertension, Steatohepatitis, Inflammation

Full registry criteria

Inclusion Criteria: * Age 13-16 years * BMI \>35 * Failed comprehensive treatment for obesity \> 1 year * Passing assessment of psychologist * Tanner 3 or more Exclusion Criteria: * Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl) * Obesity secondary to brain injury * Severely mentally disabled * Not eligible for general anesthesia * Psychotic or other major psychiatric illness * Previous major gastrointestinal surgery

Treatments and study arms

Laparoscopic Roux-en-Y gastric bypass

Procedure

Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy

Intense conservative treatment

Procedure

Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years

Primary outcomes

Body Mass Index (kg/m2)2 years after treatment initiation

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Sahlgrenska University hospital🇸🇪 Gothenburg, Sweden
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Skåne University Hospital🇸🇪 Malmö, Sweden
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Karolinska University hospital🇸🇪 Stockholm, Sweden
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