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Study on the Appropriateness of Bariatric Surgery in Adolescents

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01249950
First received: November 26, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.


Condition Intervention
Morbid Obesity
 Other: feasibility

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • potential number of patients eligible for surgery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    evaluate prospectively the potential number of patients eligible for surgery, among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity.


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
adolescents
adolescents with morbid obesity
 Other: feasibility
feasibility

Detailed Description:

This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adolescents

Criteria

Inclusion Criteria:

  • failure of weight loss in an organized care> 6 months
  • BMI > à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI > or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.
  • Patients must have completed their growth (bone age > 13 for girls and >15 for boys).
  • The teenager and his legal representative must have given their informed consent.
  • The subject must be affiliated to a social security scheme

Exclusion Criteria:

  • syndromic obesities
  • tumor-induced obesity
  • Patient with severe psychiatric disorders
  • Patient with eating disorders
  • Patients under judicial protection
  • Patient under guardianship or curatorship
  • Patient participating in another study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249950

Contacts
Contact: Béatrice JOURET, MD 05 34 55 85 56 ext 33 jouret.b@chu-toulouse.fr
Contact: Isabelle KIEFFER, Clinical Research Associate 05 67 77 13 82 ext 33 kieffer.i@chu-toulouse.fr

Locations
France
UHToulouse Recruiting
Toulouse, France, 31059
Contact: Béatrice JOURET, MD     05 34 55 85 56 ext 33     jouret.b@chu-toulouse.fr    
Contact: Isabelle KIEFFER, Clinical Research Associate     05 67 77 13 82 ext 33     kieffer.i@chu-toulouse.fr    
Sub-Investigator: Maïthé TAUBER, MD, PhD            
Principal Investigator: Béatrice JOURET, MD            
Sub-Investigator: Gwenaelle DIENE, MD            
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Béatrice JOURET, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01249950     History of Changes
Other Study ID Numbers: 08 157 02, 2008-A01320-55
Study First Received: November 26, 2010
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Morbid obesity
teenagers
co-morbidities
bariatric surgery
epidemiology

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013