Morbid ObesityFABSNCT00776776
Follow-up of Adolescent Bariatric Surgery
An observational study of Morbid Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients Seeking Treatment for Obesity at Cincinnati Children's Hosptial Medical Center in Cincinnati, OH.
Who may be able to join
- All patients seeking treatment for Obesity at Cincinnati
Who cannot join
- Currently Enrolled in Teen LABS Study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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:
- To describe the natural history of morbid obesity among adolescents who seek treatment for their obesity
- 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
- To organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies
- Conditions
- Morbid Obesity
- Keywords
- BMI > 40, Obesity, Adolescents, Weight Loss Surgery
- Medical subject headings
- Obesity, Morbid, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: Annually
Secondary outcomes (1)
Medical Co-morbidities
Measured: Annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startApr 2005
- Primary completionApr 2007
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776776
- Sponsor's protocol ID
- 2008-0954
- Acronym
- FABS
- Status last verified
- Aug 2008
- First submitted
- 20 Oct 2008
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
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 16076986Xanthakos 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 16778582Miller 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 17885457Roehrig 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 17894144Ippisch 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 18387434Inge 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Adolescent Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00776776
- Acronym / sponsor ID
- FABS / 2008-0954
- Conditions
- Morbid Obesity
- Keywords
- BMI > 40, Obesity, Adolescents, Weight Loss Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Apr 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To describe the natural history of morbid obesity among adolescents who seek treatment for their obesity
- 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
- To organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients Seeking Treatment for Obesity at Cincinnati Children's Hosptial Medical Center in Cincinnati, OH.
Key inclusion criteria (1 listed)
- All patients seeking treatment for Obesity at Cincinnati
Key exclusion criteria (1 listed)
- Currently Enrolled in Teen LABS Study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMI
Time frame: Annually
1 secondary outcome
Medical Co-morbidities
Time frame: Annual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Results publication: PubMed 16076986Kalra 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.
- Results publication: PubMed 16778582Xanthakos 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.
- Results publication: PubMed 17885457Miller 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.
- Results publication: PubMed 17894144Roehrig 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.
- Results publication: PubMed 18387434Ippisch 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.
- Derived from this study: PubMed 28065736Inge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: Annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776776, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.