Clinical trial NCT02062164: Weight Loss Surgery in Adolescents With Extreme Obesity
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Extreme Obesity
Keywords: psychosocial, healthcare, co-morbidities, extremely obese adolescents
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: University of Witten/Herdecke
name: Charite University, Berlin, Germany
name: University of Leipzig
name: Universität Duisburg-Essen
First posted: 2014-02-13
Enrollment: 66
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from a cohort of young adults and adolescents participating in the "Adolescents with extreme Obesity" Study.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: BMI change from baseline
timeFrame: 1 year postoperative
Secondary outcomes:
measure: BMI
timeFrame: every 6 months for 9 years
measure: changes in somatic comorbidity
timeFrame: every 12 months for 9 years
measure: changes in psychosocial comorbidity
timeFrame: every 12 months for 9 years
measure: changes in psychiatric comorbidity
timeFrame: every 12 months for 9 years
measure: peri- und postoperative complications
timeFrame: every 12 months for 9 years
measure: vitamin deficiencies
timeFrame: every 6 months for 9 years
measure: adherence with postoperative recommendations on supplements, doctors visits and nutrition
timeFrame: every 12 months for 9 years
measure: hunger, food tolerance, gastrointestinal symptoms, dumping
timeFrame: every 12 months for 9 years
measure: eating behavior
timeFrame: every 12 months for 9 years
measure: exercise
timeFrame: every 12 months for 9 years
measure: changes in quality of life: SF36
timeFrame: every 12 months for 9 years
measure: changes in quality of life: IWQOL
timeFrame: every 12 months for 9 years
measure: schooling, vocation, psychosocial situation, functional impairments
timeFrame: every 12 months for 9 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Ambulatory Obesity Program, Charité University, Berlin
city: Datteln
country: Germany
facility: Vestische Kinderklinik, University of Witten/Herdecke
city: Essen
country: Germany
facility: University Duisburg-Essen
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Ulm
country: Germany
facility: Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Study officials:
affiliation: University of Ulm
name: Martin Wabitsch, Prof. Dr. med.
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Susanna Wiegand, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Witten/Herdecke
name: Thomas Reinehr, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universität Duisburg-Essen
name: Johannes Hebebrand, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig
name: Wieland Kiess, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ulm
name: Reinhard Holl, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: