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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
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
February 9, 2006
Last Updated
February 1, 2017
Sponsor
Göteborg University
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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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