Study on the Appropriateness of Bariatric Surgery in Adolescents
NCT ID: NCT01249950
Last Updated: 2013-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
10 participants
OBSERVATIONAL
2009-10-31
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
adolescents
adolescents with morbid obesity
feasibility
feasibility
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
feasibility
feasibility
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
13 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Toulouse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Béatrice JOURET, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UHToulouse
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-A01320-55
Identifier Type: OTHER
Identifier Source: secondary_id
08 157 02
Identifier Type: -
Identifier Source: org_study_id