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CompletedNCT00776776FABSUpdated Jul 14, 2021

Follow-up of Adolescent Bariatric Surgery

An observational study in Morbid Obesity, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-07-14.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
180
Sex
All
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Study 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
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Conditions studied

  • Morbid Obesity

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Keywords

  • BMI > 40
  • Obesity
  • Adolescents
  • Weight Loss Surgery
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In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's planned enrollment of 180 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Inclusion criteria

  • All patients seeking treatment for Obesity at Cincinnati

Exclusion criteria

Exclusion Criteria:

  • Currently Enrolled in Teen LABS Study.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
180 participants (estimated)
06

What researchers measure

Primary outcomes

  1. BMI

    Time frame: Annually

Secondary outcomes

  1. Medical Co-morbidities

    Time frame: Annual

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Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
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References and documents

Publications

  • 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. PubMed 16076986 ↗
  • 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. PubMed 16778582 ↗
  • 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. PubMed 17885457 ↗
  • 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. PubMed 17894144 ↗
  • 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. PubMed 18387434 ↗
  • 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. PubMed 28065736 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00776776
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Ethicon Endo-Surgery
First posted
Oct 21, 2008
Start date
Apr 2005
Primary completion
Apr 2007
Completion
Apr 2010
Last update
Jul 14, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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