Weight Loss Surgery in Adolescents With Extreme Obesity (YES)
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|ClinicalTrials.gov Identifier: NCT02062164|
Recruitment Status : Recruiting
First Posted : February 13, 2014
Last Update Posted : September 15, 2017
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.
|Condition or disease||Intervention/treatment|
|Obesity Extreme Obesity||Procedure: bariatric surgery Other: conservative care|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Effectiveness and Safety of Weight Loss Surgery in Adolescents With Extreme Obesity Within a Structured Pre- and Post-surgery Treatment Program, Subproject 3|
|Actual Study Start Date :||November 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2028|
bariatric surgery group
subjects who participate in the overall project and undergo bariatric surgery
Procedure: 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.
conservative care group
subjects who participate in the overall project and do not undergo bariatric surgery
Other: conservative care
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.)
- BMI change from baseline [ Time Frame: 1 year postoperative ]
- BMI [ Time Frame: every 6 months for 9 years ]
- changes in somatic comorbidity [ Time Frame: every 12 months for 9 years ]Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.
- changes in psychosocial comorbidity [ Time Frame: every 12 months for 9 years ]Will be assessed via standardized patient questionnaires.
- changes in psychiatric comorbidity [ Time Frame: every 12 months for 9 years ]Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.
- peri- und postoperative complications [ Time Frame: every 12 months for 9 years ]Will be assessed via physician questionnaires.
- vitamin deficiencies [ Time Frame: every 6 months for 9 years ]Will be assessed via patient questionnaire and laboratory studies.
- adherence with postoperative recommendations on supplements, doctors visits and nutrition [ Time Frame: every 12 months for 9 years ]Will be assessed via patient questionnaire.
- hunger, food tolerance, gastrointestinal symptoms, dumping [ Time Frame: every 12 months for 9 years ]Will be assessed via patient questionnaire.
- eating behavior [ Time Frame: every 12 months for 9 years ]Will be assessed via validated questionnaire (EDE-Q).
- exercise [ Time Frame: every 12 months for 9 years ]Will be assessed via validated questionnaire (IPAQ).
- quality of life [ Time Frame: every 12 months for 9 years ]Will be assessed via validated questionnaire (SF36, IWQOL).
- schooling, vocation, psychosocial situation, functional impairments [ Time Frame: every 12 months for 9 years ]Will be assessed via standardized patient questionnaire.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062164
|Contact: Anja Moss, Dr. biol. hum.||+49 7031 500 email@example.com|
|Contact: Belinda S Lennerz, Dr. med.||+49 7031 500 firstname.lastname@example.org|
|Ambulatory Obesity Program, Charité University, Berlin||Recruiting|
|Berlin, Germany, 13353|
|Contact: Annika Bickenbach, Dr.med. +49 30 450 566 889 email@example.com|
|Principal Investigator: Susanna Wiegand, Dr. med.|
|Sub-Investigator: Annika Bickenbach, Dr. med.|
|Vestische Kinderklinik, University of Witten/Herdecke||Recruiting|
|Contact: Anke Schaefer +49 2363 975 349 A.Schaefer@kinderklinik-datteln.de|
|Principal Investigator: Thomas Reinehr, Prof. Dr. med.|
|Sub-Investigator: Barbara Wolters, Dr. med.|
|Essen, Germany, 45147|
|Contact: Johannes Hebebrand, Prof. Dr.med. +49 201 8707 466 firstname.lastname@example.org|
|Principal Investigator: Johannes Hebebrand, Prof. Dr.med.|
|Sub-Investigator: André Scherag, Dr. rer. physiol.|
|Sub-Investigator: Claudia Ose|
|Sub-Investigator: Yvonne Mühlig, Dipl. Psych.|
|University Hospital Leipzig||Recruiting|
|Leipzig, Germany, 04103|
|Contact: Madlen Neef +49 341 9726000 Madlen.Neef@medizin.uni-leipzig.de|
|Principal Investigator: Wieland Kiess, Prof. Dr. med.|
|Sub-Investigator: Madlen Neef|
|Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic||Recruiting|
|Ulm, Germany, 89075|
|Contact: Anja S Moss, Dr. biol. hum. +49 7031 500 57401 email@example.com|
|Contact: Belinda Lennerz, Dr. med. +49 7031 500 57401 firstname.lastname@example.org|
|Principal Investigator: Martin Wabitsch, Prof. Dr. med.|
|Sub-Investigator: Belinda S Lennerz, Dr. med.|
|Sub-Investigator: Anja Moss, Dr. hum. biol.|
|Sub-Investigator: Julia von Schnurbein, Dr. med.|
|Study Chair:||Martin Wabitsch, Prof. Dr. med.||University of Ulm|
|Principal Investigator:||Susanna Wiegand, Dr. med.||Charite University, Berlin, Germany|
|Principal Investigator:||Thomas Reinehr, Prof. Dr. med.||University of Witten/Herdecke|
|Principal Investigator:||Johannes Hebebrand, Prof. Dr. med.||Universität Duisburg-Essen|
|Principal Investigator:||Wieland Kiess, Prof. Dr. med.||University of Leipzig|
|Principal Investigator:||Reinhard Holl, Prof. Dr. med.||University of Ulm|