- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02062164
Weight Loss Surgery in Adolescents With Extreme Obesity (YES)
Effectiveness and Safety of Weight Loss Surgery in Adolescents With Extreme Obesity Within a Structured Pre- and Post-surgery Treatment Program, Subproject 3
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Berlin, Germany, 13353
- Ambulatory Obesity Program, Charité University, Berlin
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Datteln, Germany
- Vestische Kinderklinik, University of Witten/Herdecke
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Essen, Germany, 45147
- University Duisburg-Essen
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Leipzig, Germany, 04103
- University Hospital Leipzig
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Ulm, Germany, 89075
- Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- BMI ≥ 35 kg/m2 with severe comorbidity or BMI ≥ 40 kg/m2 with relevant comorbidity
- completed longitudinal growth
- stable social surroundings
- exhaustion of conservative treatment
- participation in the project "Adolescents with extreme Obesity"
- adequate compliance and adherence
Exclusion Criteria:
- treatable causative condition
- unstable medical, psychosocial or psychiatric comorbidity
- alcohol or drug abuse
- pregnancy
- contraindication for bariatric surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
bariatric surgery group
subjects who participate in the overall project and undergo bariatric surgery
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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.
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conservative care group
subjects who participate in the overall project and do not undergo bariatric surgery
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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.)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BMI change from baseline
Time Frame: 1 year postoperative
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1 year postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI
Time Frame: every 6 months for 9 years
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every 6 months for 9 years
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changes in somatic comorbidity
Time Frame: every 12 months for 9 years
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Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.
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every 12 months for 9 years
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changes in psychosocial comorbidity
Time Frame: every 12 months for 9 years
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Will be assessed via standardized patient questionnaires.
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every 12 months for 9 years
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changes in psychiatric comorbidity
Time Frame: every 12 months for 9 years
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Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.
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every 12 months for 9 years
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peri- und postoperative complications
Time Frame: every 12 months for 9 years
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Will be assessed via physician questionnaires.
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every 12 months for 9 years
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vitamin deficiencies
Time Frame: every 6 months for 9 years
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Will be assessed via patient questionnaire and laboratory studies.
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every 6 months for 9 years
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adherence with postoperative recommendations on supplements, doctors visits and nutrition
Time Frame: every 12 months for 9 years
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Will be assessed via patient questionnaire.
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every 12 months for 9 years
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hunger, food tolerance, gastrointestinal symptoms, dumping
Time Frame: every 12 months for 9 years
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Will be assessed via patient questionnaire.
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every 12 months for 9 years
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eating behavior
Time Frame: every 12 months for 9 years
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Will be assessed via validated questionnaire (EDE-Q).
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every 12 months for 9 years
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exercise
Time Frame: every 12 months for 9 years
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Will be assessed via validated questionnaire (IPAQ).
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every 12 months for 9 years
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changes in quality of life: SF36
Time Frame: every 12 months for 9 years
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Will be assessed via validated questionnaires (SF36).
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every 12 months for 9 years
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changes in quality of life: IWQOL
Time Frame: every 12 months for 9 years
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Will be assessed via validated questionnaires (IWQOL).
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every 12 months for 9 years
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schooling, vocation, psychosocial situation, functional impairments
Time Frame: every 12 months for 9 years
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Will be assessed via standardized patient questionnaire.
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every 12 months for 9 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Martin Wabitsch, Prof. Dr. med., University of Ulm
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1131-4384c
- DRKS00004172 (Registry Identifier: Deutsches Register Klinischer Studien)
- 01GI1120A (Other Grant/Funding Number: Bundesministerium für Bildung und Forschung)
- U1111-1131-8145 (OTHER: overall project: Medical & psychosoc. implications of adolescent extr. obesity, acceptance & effects of structured care)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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