Follow-up of Adolescent Bariatric Surgery

NCT ID: NCT00776776

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2010-04-30

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

Conditions

Morbid Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients seeking treatment for Obesity at Cincinnati

Exclusion Criteria

• Currently Enrolled in Teen LABS Study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Cincinnati Children's Hospital Medical Center

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16076986 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16778582 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17885457 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17894144 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18387434 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28065736 (View on PubMed)

Other Identifiers

2008-0954

Identifier Type: -

Identifier Source: org_study_id