Clinical trial NCT00776776: Follow-up of Adolescent Bariatric Surgery
Official title: Follow-up of Adolescent Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: BMI > 40
Obesity
Adolescents
Weight Loss Surgery
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2008-10-21
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Seeking Treatment for Obesity at Cincinnati Children's Hosptial Medical Center in Cincinnati, OH.

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* All patients seeking treatment for Obesity at Cincinnati

Exclusion Criteria:

* Currently Enrolled in Teen LABS Study.

Primary outcomes:
measure: BMI
timeFrame: Annually
Secondary outcomes:
measure: Medical Co-morbidities
timeFrame: Annual
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
citation: Kalra M, Inge T, Garcia V, Daniels S, Lawson L, Curti R, Cohen A, Amin R. Obstructive sleep apnea in extremely overweight adolescents undergoing bariatric surgery. Obes Res. 2005 Jul;13(7):1175-9. doi: 10.1038/oby.2005.139.
citation: Xanthakos SA, Inge TH. Nutritional consequences of bariatric surgery. Curr Opin Clin Nutr Metab Care. 2006 Jul;9(4):489-96. doi: 10.1097/01.mco.0000232913.07355.cf.
citation: Miller RJ, Xanthakos SA, Hillard PJ, Inge TH. Bariatric surgery and adolescent gynecology. Curr Opin Obstet Gynecol. 2007 Oct;19(5):427-33. doi: 10.1097/GCO.0b013e3282efb285.
citation: Roehrig HR, Xanthakos SA, Sweeney J, Zeller MH, Inge TH. Pregnancy after gastric bypass surgery in adolescents. Obes Surg. 2007 Jul;17(7):873-7. doi: 10.1007/s11695-007-9162-7.
citation: Ippisch HM, Inge TH, Daniels SR, Wang B, Khoury PR, Witt SA, Glascock BJ, Garcia VF, Kimball TR. Reversibility of cardiac abnormalities in morbidly obese adolescents. J Am Coll Cardiol. 2008 Apr 8;51(14):1342-8. doi: 10.1016/j.jacc.2007.12.029.
citation: Inge TH, Jenkins TM, Xanthakos SA, Dixon JB, Daniels SR, Zeller MH, Helmrath MA. Long-term outcomes of bariatric surgery in adolescents with severe obesity (FABS-5+): a prospective follow-up analysis. Lancet Diabetes Endocrinol. 2017 Mar;5(3):165-173. doi: 10.1016/S2213-8587(16)30315-1. Epub 2017 Jan 6.