Surgical Intervention for Morbidly Obese Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00289705
First received: February 9, 2006
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Obesity
Diabetes
Hypertension
Procedure: Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • BMI development [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2006
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery
Laparoscopic gastric bypass
Procedure: Surgery
Laparoscopic Roux-en-Y gastric bypass
No Intervention: 2
Traditional treatment for obesity

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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289705

Locations
Sweden
Queen Silvias Children Hospital
Gothenburg, Göteborg, Sweden
Sahlgrenska University Hospital, Dept of Surgery
Gothenburg, Sweden, 41345
Dept of Pediatrics, MAS
Malmö, Sweden
National center for child obesity, Karolinska Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Torsten Olbers, MD, PhD Sahlgrenska University Hospital, Sweden
Study Chair: 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
  More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00289705     History of Changes
Other Study ID Numbers: SU523-04
Study First Received: February 9, 2006
Last Updated: December 17, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Göteborg University:
Obesity
Surgery
Adolescent
Roux-en-Y gastric bypass
Laparoscopic

Additional relevant MeSH terms:
Hypertension
Obesity
Body Weight
Cardiovascular Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014