Follow-up of Adolescent Bariatric Surgery (FABS)

• ClinicalTrials.gov Identifier: NCT00776776
• Recruitment Status: Completed
• First Posted: October 21, 2008
• Last Update Posted: July 14, 2021
• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Ethicon Endo-Surgery
• Information provided by: Children's Hospital Medical Center, Cincinnati

Study Description

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

Condition or disease
Morbid Obesity

Study Design

• Study Type: Observational
• Estimated Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Follow-up of Adolescent Bariatric Surgery
• Study Start Date: April 2005
• Actual Primary Completion Date: April 2007
• Actual Study Completion Date: April 2010

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. BMI [ Time Frame: Annually ]

Secondary Outcome Measures :

1. Medical Co-morbidities [ Time Frame: Annual ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients Seeking Treatment for Obesity at Cincinnati Children's Hosptial Medical Center in Cincinnati, OH.

Criteria

Inclusion Criteria:

• All patients seeking treatment for Obesity at Cincinnati

Exclusion Criteria:

• Currently Enrolled in Teen LABS Study.

Contacts and Locations

Locations

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Ethicon Endo-Surgery

More Information

Publications of Results:

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Thomas H. Inge, MD, PhD, Principal Investigator, Cincinnati Children's Hospital Medical Center
• ClinicalTrials.gov Identifier: NCT00776776
• Other Study ID Numbers: 2008-0954
• First Posted: October 21, 2008
• Last Update Posted: July 14, 2021
• Last Verified: August 2008

Keywords provided by Children's Hospital Medical Center, Cincinnati:

BMI > 40; Obesity; Adolescents; Weight Loss Surgery

Additional relevant MeSH terms:

Obesity, Morbid; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight