Surgical Intervention for Morbidly Obese Adolescents

NCT00289705 | Unknown Phase 3 DMC

• 1 other identifier: SU523-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Obesity; Diabetes; Hypertension

Keywords

Obesity; Surgery; Adolescent; Roux-en-Y gastric bypass; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• BMI development

  10 years

Secondary Outcomes (1)

• Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.

  10 years

Study Arms (2)

Surgery

EXPERIMENTAL

Laparoscopic gastric bypass

Procedure: Surgery

2

NO INTERVENTION

Traditional treatment for obesity

Interventions

Surgery PROCEDURE

Laparoscopic Roux-en-Y gastric bypass

Surgery

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (4)

Sahlgrenska University Hospital, Dept of Surgery

Gothenburg, Gothenburg, 41345, Sweden

Location

Queen Silvias Children Hospital

Gothenburg, Göteborg, Sweden

Location

Dept of Pediatrics, MAS

Malmo, Malmö, Sweden

Location

National center for child obesity, Karolinska Huddinge

Stockholm, Stockholm County, 14186, Sweden

Location

Related Publications (5)

• 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.

  PMID: 33079376 DERIVED

• 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.

  PMID: 31978372 DERIVED

• 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.

  PMID: 28065734 DERIVED

• 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.

  PMID: 27071497 DERIVED

• 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.

  PMID: 24491362 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Hypertension

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Torsten Olbers, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

• Clude Marcus, Prof, MD

  Dept of Pediatrics, Karolinska University Hospital, Huddinge

  STUDY CHAIR

• Staffan Mårild, MD, PhD

  Queen Silvias Childs Hospital, Gothenburg

  STUDY CHAIR

• Carl-Erik Flodmark, MD, PhD

  Dept of Pediatrics, MAS, Malmö

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

SE (4)