Clinical trial NCT00289705: Surgical Intervention for Morbidly Obese Adolescents
Official title: Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Diabetes
Hypertension
Keywords: Obesity
Surgery
Adolescent
Roux-en-Y gastric bypass
Laparoscopic
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2006-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.

Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.

Detailed description: Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI \>40kg/m2 in the adolescence will remain morbidly obese also in their adult life.

The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.

Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.

Eligibility criteria: Inclusion Criteria:

* BMI \>40 kg/m2 or BMI\>35 with comorbidity
* Pass psychological evaluation
* Puberty status Tanner 4-5
* At least one year with active conservative treatment that failed

Exclusion Criteria:

* Lack of compliance
* Specific obesity syndrome as Praeder Willis
* Obesity due to brain injury
* Severe general disease
* Specific genetic defect (MC4R, Leptin deficiency)

Primary outcomes:
measure: BMI development
timeFrame: 10 years
Secondary outcomes:
measure: Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.
timeFrame: 10 years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Queen Silvias Children Hospital
state: Göteborg
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Dept of Surgery
city: Malmö
country: Sweden
facility: Dept of Pediatrics, MAS
city: Stockholm
country: Sweden
facility: National center for child obesity, Karolinska Huddinge
Study officials:
affiliation: Sahlgrenska University Hospital
name: Torsten Olbers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Pediatrics, Karolinska University Hospital, Huddinge
name: Clude Marcus, Prof, MD
role: STUDY_CHAIR
affiliation: Queen Silvias Childs Hospital, Gothenburg
name: Staffan Mårild, MD, PhD
role: STUDY_CHAIR
affiliation: Dept of Pediatrics, MAS, Malmö
name: Carl-Erik Flodmark, MD, PhD
role: STUDY_CHAIR
References:
citation: Jarvholm K, Olbers T, Peltonen M, Marcus C, Flodmark CE, Gronowitz E, Dahlgren J, Karlsson J. Depression, anxiety, and suicidal ideation in young adults 5 years after undergoing bariatric surgery as adolescents. Eat Weight Disord. 2021 May;26(4):1211-1221. doi: 10.1007/s40519-020-01024-0. Epub 2020 Oct 20.
citation: Jarvholm K, Bruze G, Peltonen M, Marcus C, Flodmark CE, Henfridsson P, Beamish AJ, Gronowitz E, Dahlgren J, Karlsson J, Olbers T. 5-year mental health and eating pattern outcomes following bariatric surgery in adolescents: a prospective cohort study. Lancet Child Adolesc Health. 2020 Mar;4(3):210-219. doi: 10.1016/S2352-4642(20)30024-9. Epub 2020 Jan 21.
citation: Olbers T, Beamish AJ, Gronowitz E, Flodmark CE, Dahlgren J, Bruze G, Ekbom K, Friberg P, Gothberg G, Jarvholm K, Karlsson J, Marild S, Neovius M, Peltonen M, Marcus C. Laparoscopic Roux-en-Y gastric bypass in adolescents with severe obesity (AMOS): a prospective, 5-year, Swedish nationwide study. Lancet Diabetes Endocrinol. 2017 Mar;5(3):174-183. doi: 10.1016/S2213-8587(16)30424-7. Epub 2017 Jan 6.
citation: Beamish AJ, Gronowitz E, Olbers T, Flodmark CE, Marcus C, Dahlgren J. Body composition and bone health in adolescents after Roux-en-Y gastric bypass for severe obesity. Pediatr Obes. 2017 Jun;12(3):239-246. doi: 10.1111/ijpo.12134. Epub 2016 Apr 12.
citation: Gothberg G, Gronowitz E, Flodmark CE, Dahlgren J, Ekbom K, Marild S, Marcus C, Olbers T. Laparoscopic Roux-en-Y gastric bypass in adolescents with morbid obesity--surgical aspects and clinical outcome. Semin Pediatr Surg. 2014 Feb;23(1):11-6. doi: 10.1053/j.sempedsurg.2013.10.015. Epub 2013 Nov 15.