Weight Loss Surgery in Adolescents With Extreme Obesity (YES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Ulm
Sponsor:
Collaborators:
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
Information provided by (Responsible Party):
Prof. Dr. Martin Wabitsch, University of Ulm
ClinicalTrials.gov Identifier:
NCT02062164
First received: October 22, 2013
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obesity
Extreme Obesity
Procedure: bariatric surgery
Other: conservative care

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • BMI change from baseline [ Time Frame: 1 year postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMI [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
  • changes in somatic comorbidity [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: Yes ]
    Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.

  • changes in psychosocial comorbidity [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: Yes ]
    Will be assessed via standardized patient questionnaires.

  • changes in psychiatric comorbidity [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: Yes ]
    Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.

  • peri- und postoperative complications [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: Yes ]
    Will be assessed via physician questionnaires.

  • vitamin deficiencies [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: Yes ]
    Will be assessed via patient questionnaire and laboratory studies.

  • adherence with postoperative recommendations on supplements, doctors visits and nutrition [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    Will be assessed via patient questionnaire.

  • hunger, food tolerance, gastrointestinal symptoms, dumping [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: Yes ]
    Will be assessed via patient questionnaire.

  • eating behavior [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    Will be assessed via validated questionnaire (EDE-Q).

  • exercise [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    Will be assessed via validated questionnaire (IPAQ).

  • quality of life [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    Will be assessed via validated questionnaire (SF36, IWQOL).

  • schooling, vocation, psychosocial situation, functional impairments [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    Will be assessed via standardized patient questionnaire.


Biospecimen Retention:   Samples With DNA

Samples of fasting plasma, serum, DNA, urine, visceral and subcutaneous fat will be retained.


Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
bariatric surgery group
subjects who participate in the overall project and undergo bariatric surgery
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.
conservative care group
subjects who participate in the overall project and do not undergo bariatric surgery
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.)

  Eligibility

Ages Eligible for Study:   14 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062164

Contacts
Contact: Anja Moss, Dr. biol. hum. +49 7031 500 57401 ja-studie@uni-ulm.de
Contact: Belinda S Lennerz, Dr. med. +49 7031 500 57401 ja-studie@uni-ulm.de

Locations
Germany
Ambulatory Obesity Program, Charité University, Berlin Recruiting
Berlin, Germany, 13353
Contact: Annika Bickenbach, Dr.med.    +49 30 450 566 889    babeluga@charite.de   
Principal Investigator: Susanna Wiegand, Dr. med.         
Sub-Investigator: Annika Bickenbach, Dr. med.         
Vestische Kinderklinik, University of Witten/Herdecke Recruiting
Datteln, Germany
Contact: Anke Schaefer    +49 2363 975 349    A.Schaefer@kinderklinik-datteln.de   
Principal Investigator: Thomas Reinehr, Prof. Dr. med.         
Sub-Investigator: Barbara Wolters, Dr. med.         
University Duisburg-Essen Recruiting
Essen, Germany, 45147
Contact: Johannes Hebebrand, Prof. Dr.med.    +49 201 8707 466    ja-studie@uni-due.de   
Principal Investigator: Johannes Hebebrand, Prof. Dr.med.         
Sub-Investigator: André Scherag, Dr. rer. physiol.         
Sub-Investigator: Claudia Ose         
Sub-Investigator: Yvonne Mühlig, Dipl. Psych.         
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Madlen Neef    +49 341 9726000    Madlen.Neef@medizin.uni-leipzig.de   
Principal Investigator: Wieland Kiess, Prof. Dr. med.         
Sub-Investigator: Madlen Neef         
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic Recruiting
Ulm, Germany, 89075
Contact: Anja S Moss, Dr. biol. hum.    +49 7031 500 57401    ja-studie@uni-ulm.de   
Contact: Belinda Lennerz, Dr. med.    +49 7031 500 57401    ja-studie@uni-ulm.de   
Principal Investigator: Martin Wabitsch, Prof. Dr. med.         
Sub-Investigator: Belinda S Lennerz, Dr. med.         
Sub-Investigator: Anja Moss, Dr. hum. biol.         
Sponsors and Collaborators
Prof. Dr. Martin Wabitsch
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
Investigators
Study Chair: Martin Wabitsch, Prof. Dr. med. University of Ulm
Principal Investigator: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Martin Wabitsch, Division Chief Pediatric Endocrinology and Diabetology, University of Ulm
ClinicalTrials.gov Identifier: NCT02062164     History of Changes
Other Study ID Numbers: U1111-1131-4384c, DRKS00004172, 01GI1120A, U1111-1131-8145
Study First Received: October 22, 2013
Last Updated: February 10, 2014
Health Authority: Germany: Federal Ministry of Education and Research
Germany: Ethics Commission

Keywords provided by University of Ulm:
psychosocial, healthcare, co-morbidities, extremely obese adolescents

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on October 19, 2014