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Effectiveness and Safety of Weight Loss Surgery in Adolescents With Extreme Obesity Within a Structured Pre- and Post-surgery Treatment Program, Subproject 3
Sponsor study identifier
Secondary identifiers
REGISTRY · Deutsches Register Klinischer Studien
OTHER_GRANT · German Ministry for Education and Research (BMBF)
OTHER · UTN of overall project
observational
66
1 country
5
Study Start
November 2013
Actual (reported)Primary Completion
April 2018
Actual (reported)Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery is the only effective treatment to achieve sustained weight loss in adults with extreme obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric surgery is equally effective; however, due to the paucity of long-term data, the long-term effects and risks are unknown. Thus, due to surgical risk and ethical implications, bariatric surgery is considered experimental in Germany. Nevertheless, case volumes are increasing. The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery in the context of a structured preparation and follow-up program. The study is a subproject of the study "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care" (DRKS00004172). At 5 German university centers (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are participants in the overall project will be enrolled in a structured preparation and follow-up program. The program is designed to improve adherence and compliance and will result in comprehensive follow-up data. In addition to the data gathered in the overall project, subjects participating in subproject 3 will undergo assessments pertinent to bariatric surgery, as proposed in the American Teen-LABS study (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison will be made with BMI matched adolescents who participate in the overall project but do not undergo bariatric surgery. In November 2014 recruitment for the overall project was completed. However, patients interested in bariatric surgery will still be recruited until September 2016. There assessment will be the same as for patients recruited earlier. However, in an amendment in December 2014, the frequency of assessment via questionnaire was reduced from biannually to annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2013
Actual (reported)November 2013
Actual (reported)February 13, 2014
Actual (reported)April 2018
Actual (reported)January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
BMI change from baseline
1 year postoperative
BMI
every 6 months for 9 years
changes in somatic comorbidity
every 12 months for 9 years
changes in psychosocial comorbidity
every 12 months for 9 years
changes in psychiatric comorbidity
every 12 months for 9 years
peri- und postoperative complications
every 12 months for 9 years
subjects who participate in the overall project and undergo bariatric surgery
subjects who participate in the overall project and do not undergo bariatric surgery
The intervention takes place in the clinical care setting. The decision for surgery is made by a multidisciplinary team, according to the international guidelines and the recommendations of the German working group on obesity (AGA, www.a.g.a.de). The choice of procedure is made on an individual basis taking into consideration patient inherent factors as well as the recommendations of the operating center. Operations are conducted at certified bariatric centers according to the policies of the German working group on bariatric surgery (CAADIP), and in the context of a structured preparation and follow-up program. The program is offered by a multidisciplinary team (pediatrician, endocrinologist, surgeon, dietician, psychologist/psychiatrist, social worker) and comprises preparation for and education about the surgery and expected lifestyle changes, as well as a structured, multidisciplinary follow-up plan. Subjects sign a contract agreeing to adhere to the recommended follow-up schedule.
Subjects will be recruited from a cohort of young adults and adolescents participating in the "Adolescents with extreme Obesity" Study.
Ambulatory Obesity Program, Charité University, Berlin
Berlin, 13353, Germany
Vestische Kinderklinik, University of Witten/Herdecke
Datteln, Germany
University Duisburg-Essen
Essen, 45147, Germany
University Hospital Leipzig
Leipzig, 04103, Germany
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Ulm, 89075, Germany
Samples of fasting plasma, serum, DNA, urine, visceral and subcutaneous fat will be retained.
Martin Wabitsch, Prof. Dr. med.
University of Ulm
Susanna Wiegand, Dr. med.
Charite University, Berlin, Germany
Thomas Reinehr, Prof. Dr. med.
University of Witten/Herdecke
Johannes Hebebrand, Prof. Dr. med.
Universität Duisburg-Essen
66 participants (actual enrollment reported by the registry).
First Submitted
October 22, 2013
First Posted
February 13, 2014
Study Start
November 2013
Actual (reported)Subjects will be seen by a trained study physician every 6 months. Stuctured health assessments will be conducted, and individual treatment recommendations will be made based on the patients motivation and ability(e.g. inpatient obesity rehab, exercise, dietary or behavioral intervention etc.)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Wieland Kiess, Prof. Dr. med.
University of Leipzig
Reinhard Holl, Prof. Dr. med.
University of Ulm
Primary Completion
April 2018
Actual (reported)Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 8, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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