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Completed

NCT Number: NCT00776776

Follow-up of Adolescent Bariatric Surgery

Very little information is available about extremely obese (body mass index [BMI] > 40 kg/m2) adolescents. The purpose of the Follow up of Adolescent Bariatric Surgery (FABS) study is to collect information obtained during the clinical care of obese adolescents from all over the country that can be used by researchers to study obesity, the complications of obesity, and the outcomes of obesity treatment during adolescence. This information will be used to describe the experience of the obese adolescent, including how obesity during adolescence and its treatment impacts health and well-being. The information may also be used to study causes of obesity, to determine the predictors of successful obesity treatment and for other obesity related research. Because of the importance of understanding the outcome of obesity and obesity treatments (surgical and non-surgical) on the patient over time, the data included in the study will be collected before, during and after any treatments rendered. For those who do not undergo a treatment which results in major weight change, it will be critical to determine the natural history of adolescent severe obesity as the adolescent transitions into adulthood. Finally, another important purpose of the FABS research study is to obtain patients' consent to be contacted for possible participation in future research studies.

SPECIFIC AIMS:

1. To describe the natural history of morbid obesity among adolescents who seek treatment for their obesity 2. To describe major outcomes following bariatric surgery in adolescents evaluated at 3, 6, 12, and annually for 10 years post-operatively and compare these to outcomes to patients managed non-surgically 3. To organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients seeking treatment for Obesity at Cincinnati

Exclusion criteria

  • Currently Enrolled in Teen LABS Study.

Treatment and study plan

Primary outcomes

  1. BMI

    Time frame: Annually

Secondary outcomes

  1. Medical Co-morbidities

    Time frame: Annual

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Ethicon Endo-Surgery

Registry information

Acronym: FABS

Important dates

Study start
2005
Primary completion
2007
Study completion
2010
First posted
Oct 21, 2008
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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