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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00004172 | Registry Identifier | Deutsches Register Klinischer Studien | |
| 01GI1120A | Other Grant/Funding Number | German Ministry for Education and Research (BMBF) | |
| U1111-1131-8145 | Other Identifier | UTN of overall project |
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| Name | Class |
|---|---|
| University of Witten/Herdecke | OTHER |
| Charite University, Berlin, Germany | OTHER |
| University of Leipzig | OTHER |
| Universität Duisburg-Essen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bariatric surgery group | subjects who participate in the overall project and undergo bariatric surgery |
| |
| conservative care group | subjects who participate in the overall project and do not undergo bariatric surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bariatric surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI change from baseline | 1 year postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | every 6 months for 9 years | |
| changes in somatic comorbidity | Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from a cohort of young adults and adolescents participating in the "Adolescents with extreme Obesity" Study.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Wabitsch, Prof. Dr. med. | University of Ulm | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Obesity Program, Charité University, Berlin | Berlin | 13353 | Germany | |||
| Vestische Kinderklinik, University of Witten/Herdecke |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
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Samples of fasting plasma, serum, DNA, urine, visceral and subcutaneous fat will be retained.
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| conservative care | Other | 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.) |
|
| every 12 months for 9 years |
| changes in psychosocial comorbidity | Will be assessed via standardized patient questionnaires. | every 12 months for 9 years |
| changes in psychiatric comorbidity | Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires. | every 12 months for 9 years |
| peri- und postoperative complications | Will be assessed via physician questionnaires. | every 12 months for 9 years |
| vitamin deficiencies | Will be assessed via patient questionnaire and laboratory studies. | every 6 months for 9 years |
| adherence with postoperative recommendations on supplements, doctors visits and nutrition | Will be assessed via patient questionnaire. | every 12 months for 9 years |
| hunger, food tolerance, gastrointestinal symptoms, dumping | Will be assessed via patient questionnaire. | every 12 months for 9 years |
| eating behavior | Will be assessed via validated questionnaire (EDE-Q). | every 12 months for 9 years |
| exercise | Will be assessed via validated questionnaire (IPAQ). | every 12 months for 9 years |
| changes in quality of life: SF36 | Will be assessed via validated questionnaires (SF36). | every 12 months for 9 years |
| changes in quality of life: IWQOL | Will be assessed via validated questionnaires (IWQOL). | every 12 months for 9 years |
| schooling, vocation, psychosocial situation, functional impairments | Will be assessed via standardized patient questionnaire. | every 12 months for 9 years |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |