Weight Loss Surgery in Adolescents With Extreme Obesity

NCT ID: NCT02062164

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2028-01-31

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.

Conditions

Obesity; Extreme Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

bariatric surgery group

subjects who participate in the overall project and undergo bariatric surgery

bariatric surgery

Intervention Type: 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.

conservative care group

subjects who participate in the overall project and do not undergo bariatric surgery

conservative care

Intervention Type: 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.)

Interventions

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.

Intervention Type: PROCEDURE

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.)

Intervention Type: OTHER

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role: collaborator

Prof. Dr. Martin Wabitsch

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Martin Wabitsch

Division Chief Pediatric Endocrinology and Diabetology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Wabitsch, Prof. Dr. med.

Role: STUDY_CHAIR

University of Ulm

Susanna Wiegand, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Thomas Reinehr, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Witten/Herdecke

Johannes Hebebrand, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universität Duisburg-Essen

Wieland Kiess, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Reinhard Holl, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

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, , Germany

Countries

Germany

Other Identifiers

DRKS00004172

Identifier Type: REGISTRY

Identifier Source: secondary_id

01GI1120A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U1111-1131-8145

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1131-4384c

Identifier Type: -

Identifier Source: org_study_id