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Clinical Trials in Sweden / NCT02378259
Active, not recruiting Not applicable

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

NCT02378259 · tracked via the Priya Life Science Sweden tracker
Sponsor
Göteborg University
Phase
Not applicable
Started
2014-08-15
Last updated
2022-03-25

Condition(s) studied

ObesityDiabetesHypertensionSteatohepatitisInflammation

Investigational drug(s) / intervention(s)

Laparoscopic Roux-en-Y gastric bypassIntense conservative treatment

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

Intense conservative treatment: 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

Study summary

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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
16 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (3)

FacilityCityRegionStatus
Sahlgrenska University hospital Gothenburg Sweden
Skåne University Hospital Malmö Sweden
Karolinska University hospital Stockholm Sweden

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Other trials for the same condition

Sustainable Hypertension Management in Primary Health Care in Sweden Recruiting
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery Recruiting
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Recruiting
Nutrition and Inflammation in Patients With Head and Neck Cancer Active, not recruiting
Internet Treatment for Patients With Obesity Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02378259 on ClinicalTrials.gov ↗ ← All trials in Sweden