Surgical Intervention for Morbidly Obese Adolescents
Primary Purpose
Obesity, Diabetes, Hypertension
Status
Unknown status
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Surgery
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Surgery, Adolescent, Roux-en-Y gastric bypass, Laparoscopic
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)
Sites / Locations
- Queen Silvias Children Hospital
- Sahlgrenska University Hospital, Dept of Surgery
- Dept of Pediatrics, MAS
- National center for child obesity, Karolinska Huddinge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Surgery
2
Arm Description
Laparoscopic gastric bypass
Traditional treatment for obesity
Outcomes
Primary Outcome Measures
BMI development
Secondary Outcome Measures
Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00289705
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes, Hypertension
Keywords
Obesity, Surgery, Adolescent, Roux-en-Y gastric bypass, Laparoscopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Laparoscopic gastric bypass
Arm Title
2
Arm Type
No Intervention
Arm Description
Traditional treatment for obesity
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Laparoscopic Roux-en-Y gastric bypass
Primary Outcome Measure Information:
Title
BMI development
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten Olbers, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clude Marcus, Prof, MD
Organizational Affiliation
Dept of Pediatrics, Karolinska University Hospital, Huddinge
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Staffan Mårild, MD, PhD
Organizational Affiliation
Queen Silvias Childs Hospital, Gothenburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carl-Erik Flodmark, MD, PhD
Organizational Affiliation
Dept of Pediatrics, MAS, Malmö
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Silvias Children Hospital
City
Gothenburg
State/Province
Göteborg
Country
Sweden
Facility Name
Sahlgrenska University Hospital, Dept of Surgery
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Dept of Pediatrics, MAS
City
Malmö
Country
Sweden
Facility Name
National center for child obesity, Karolinska Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33079376
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.
Results Reference
derived
PubMed Identifier
31978372
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.
Results Reference
derived
PubMed Identifier
28065734
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. Erratum In: Lancet Diabetes Endocrinol. 2017 May;5(5):e3.
Results Reference
derived
PubMed Identifier
27071497
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.
Results Reference
derived
PubMed Identifier
24491362
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.
Results Reference
derived
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Surgical Intervention for Morbidly Obese Adolescents
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