Weight Loss Surgery in Adolescents With Extreme Obesity

Obesity Clinical Trial

— YES  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02062164
• Other study ID #: U1111-1131-4384c
• Secondary ID: DRKS0000417201GI
• Status: Active, not recruiting
• Start date: November 2013
• Est. completion date: January 2028

Study information

• Verified date: May 2024
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: January 2028
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Extreme Obesity
• Obesity
• Weight Loss

Intervention

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.

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.)

Locations

Country	Name	City	State
Germany	Ambulatory Obesity Program, Charité University, Berlin	Berlin
Germany	Vestische Kinderklinik, University of Witten/Herdecke	Datteln
Germany	University Duisburg-Essen	Essen
Germany	University Hospital Leipzig	Leipzig
Germany	Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic	Ulm

Sponsors (5)

Lead Sponsor	Collaborator
Prof. Dr. Martin Wabitsch	Charite University, Berlin, Germany, Universität Duisburg-Essen, University of Leipzig, University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI change from baseline		1 year postoperative
Secondary	BMI		every 6 months for 9 years
Secondary	changes in somatic comorbidity	Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.	every 12 months for 9 years
Secondary	changes in psychosocial comorbidity	Will be assessed via standardized patient questionnaires.	every 12 months for 9 years
Secondary	changes in psychiatric comorbidity	Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.	every 12 months for 9 years
Secondary	peri- und postoperative complications	Will be assessed via physician questionnaires.	every 12 months for 9 years
Secondary	vitamin deficiencies	Will be assessed via patient questionnaire and laboratory studies.	every 6 months for 9 years
Secondary	adherence with postoperative recommendations on supplements, doctors visits and nutrition	Will be assessed via patient questionnaire.	every 12 months for 9 years
Secondary	hunger, food tolerance, gastrointestinal symptoms, dumping	Will be assessed via patient questionnaire.	every 12 months for 9 years
Secondary	eating behavior	Will be assessed via validated questionnaire (EDE-Q).	every 12 months for 9 years
Secondary	exercise	Will be assessed via validated questionnaire (IPAQ).	every 12 months for 9 years
Secondary	changes in quality of life: SF36	Will be assessed via validated questionnaires (SF36).	every 12 months for 9 years
Secondary	changes in quality of life: IWQOL	Will be assessed via validated questionnaires (IWQOL).	every 12 months for 9 years
Secondary	schooling, vocation, psychosocial situation, functional impairments	Will be assessed via standardized patient questionnaire.	every 12 months for 9 years

External Links

•   study homepage