Weight Loss Surgery in Adolescents With Extreme Obesity

NCT02062164 | Active Not Recruiting DMC

• 4 other identifiers: U1111-1131-4384cDRKS0000417201GI1120AU1111-1131-8145
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 5

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

Keywords

psychosocial, healthcare, co-morbidities, extremely obese adolescents

Outcome Measures

Primary Outcomes (1)

• BMI change from baseline

  1 year postoperative

Secondary Outcomes (13)

• BMI

  every 6 months for 9 years

• changes in somatic comorbidity

  every 12 months for 9 years

• changes in psychosocial comorbidity

  every 12 months for 9 years

• changes in psychiatric comorbidity

  every 12 months for 9 years

• peri- und postoperative complications

  every 12 months for 9 years

Study Arms (2)

bariatric surgery group

subjects who participate in the overall project and undergo bariatric surgery

Procedure: bariatric surgery

conservative care group

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

Other: conservative care

Interventions

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.

bariatric surgery group

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.)

conservative care group

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• treatable causative condition
• unstable medical, psychosocial or psychiatric comorbidity
• alcohol or drug abuse
• pregnancy
• contraindication for bariatric surgery

Sponsors & Collaborators

• Prof. Dr. Martin Wabitsch: lead
• University of Witten/Herdecke: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Leipzig: collaborator
• Universität Duisburg-Essen: collaborator

Study Sites (5)

Ambulatory Obesity Program, Charité University, Berlin

Berlin, 13353, Germany

Location

Vestische Kinderklinik, University of Witten/Herdecke

Datteln, Germany

Location

University Duisburg-Essen

Essen, 45147, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

Ulm, 89075, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Chief Pediatric Endocrinology and Diabetology

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: February 13, 2014
• Study Start: November 1, 2013
• Primary Completion: April 1, 2018
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

DE (5)