ObesityYESNCT02062164
Weight Loss Surgery in Adolescents With Extreme Obesity
An observational study of Obesity and Extreme Obesity, run by Prof. Dr. Martin Wabitsch at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Obesity, Extreme Obesity
- What is being tested?
- bariatric surgery and conservative care
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 5 sitesGermany
- Study dates
- Nov 2013to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects will be recruited from a cohort of young adults and adolescents participating in the "Adolescents with extreme Obesity" Study.
Who may be able to join
- 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
Who cannot join
- treatable causative condition
- unstable medical, psychosocial or psychiatric comorbidity
- alcohol or drug abuse
- pregnancy
- contraindication for bariatric surgery
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Ambulatory Obesity Program, Charité University, Berlin
Berlin, 13353
Vestische Kinderklinik, University of Witten/Herdecke
Datteln
University Duisburg-Essen
Essen, 45147
University Hospital Leipzig
Leipzig, 04103
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Ulm, 89075
About this study
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
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
- Being tested
- bariatric surgery, conservative care
- Keywords
- psychosocial, healthcare, co-morbidities, extremely obese adolescents
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or 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 careOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery group | subjects who participate in the overall project and undergo bariatric surgery Receives: Procedure: bariatric surgery | |
| conservative care group | subjects who participate in the overall project and do not undergo bariatric surgery Receives: Other: conservative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI change from baseline
Measured: 1 year postoperative
Secondary outcomes (13)
BMI
Measured: every 6 months for 9 years
changes in somatic comorbidity
Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.
Measured: every 12 months for 9 years
changes in psychosocial comorbidity
Will be assessed via standardized patient questionnaires.
Measured: every 12 months for 9 years
changes in psychiatric comorbidity
Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.
Measured: every 12 months for 9 years
peri- und postoperative complications
Will be assessed via physician questionnaires.
Measured: every 12 months for 9 years
vitamin deficiencies
Will be assessed via patient questionnaire and laboratory studies.
Measured: every 6 months for 9 years
adherence with postoperative recommendations on supplements, doctors visits and nutrition
Will be assessed via patient questionnaire.
Measured: every 12 months for 9 years
hunger, food tolerance, gastrointestinal symptoms, dumping
Will be assessed via patient questionnaire.
Measured: every 12 months for 9 years
eating behavior
Will be assessed via validated questionnaire (EDE-Q).
Measured: every 12 months for 9 years
exercise
Will be assessed via validated questionnaire (IPAQ).
Measured: every 12 months for 9 years
changes in quality of life: SF36
Will be assessed via validated questionnaires (SF36).
Measured: every 12 months for 9 years
changes in quality of life: IWQOL
Will be assessed via validated questionnaires (IWQOL).
Measured: every 12 months for 9 years
schooling, vocation, psychosocial situation, functional impairments
Will be assessed via standardized patient questionnaire.
Measured: every 12 months for 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2018
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Martin Wabitsch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witten/Herdecke, Charite University, Berlin, Germany, University of Leipzig, Universität Duisburg-Essen
- Responsible party
- Sponsor-investigator, Prof. Dr. Martin Wabitsch, University of Ulm
- Investigators
- Martin Wabitsch, Prof. Dr. med., Study chair, University of UlmSusanna Wiegand, Dr. med., Principal investigator, Charite University, Berlin, GermanyThomas Reinehr, Prof. Dr. med., Principal investigator, University of Witten/HerdeckeJohannes Hebebrand, Prof. Dr. med., Principal investigator, Universität Duisburg-EssenWieland Kiess, Prof. Dr. med., Principal investigator, University of LeipzigReinhard Holl, Prof. Dr. med., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062164
- Sponsor's protocol ID
- U1111-1131-4384c
- Other IDs
- DRKS00004172, 01GI1120A, U1111-1131-8145
- Acronym
- YES
- Status last verified
- May 2024
- First submitted
- 22 Oct 2013
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02062164
- Acronym / sponsor ID
- YES / U1111-1131-4384c
- Conditions
- Obesity, Extreme Obesity
- Keywords
- psychosocial, healthcare, co-morbidities, extremely obese adolescents
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Prof. Dr. Martin WabitschUniversity, hospital or other
- Collaborators
- University of Witten/Herdecke, Charite University, Berlin, Germany, University of Leipzig, Universität Duisburg-Essen
- Study start
- Nov 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery group | – | Procedure: bariatric surgerysubjects who participate in the overall project and undergo bariatric surgery |
| conservative care group | – | Other: conservative caresubjects who participate in the overall project and do not undergo bariatric surgery |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be recruited from a cohort of young adults and adolescents participating in the "Adolescents with extreme Obesity" Study.
Key inclusion criteria (6 listed)
- 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"
Key exclusion criteria (5 listed)
- treatable causative condition
- unstable medical, psychosocial or psychiatric comorbidity
- alcohol or drug abuse
- pregnancy
- contraindication for bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgeryThe 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. | Procedure or surgery | bariatric surgery group |
| conservative careSubjects 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.) | Other | conservative care group |
Primary outcome
BMI change from baseline
Time frame: 1 year postoperative
13 secondary outcomes
BMI
Time frame: every 6 months for 9 years
changes in somatic comorbidity
Time frame: every 12 months for 9 years
changes in psychosocial comorbidity
Time frame: every 12 months for 9 years
changes in psychiatric comorbidity
Time frame: every 12 months for 9 years
peri- und postoperative complications
Time frame: every 12 months for 9 years
vitamin deficiencies
Time frame: every 6 months for 9 years
adherence with postoperative recommendations on supplements, doctors visits and nutrition
Time frame: every 12 months for 9 years
hunger, food tolerance, gastrointestinal symptoms, dumping
Time frame: every 12 months for 9 years
eating behavior
Time frame: every 12 months for 9 years
exercise
Time frame: every 12 months for 9 years
changes in quality of life: SF36
Time frame: every 12 months for 9 years
changes in quality of life: IWQOL
Time frame: every 12 months for 9 years
schooling, vocation, psychosocial situation, functional impairments
Time frame: every 12 months for 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Wabitsch, Prof. Dr. med. study chair
University of Ulm
Susanna Wiegand, Dr. med. principal investigator
Charite University, Berlin, Germany
Thomas Reinehr, Prof. Dr. med. principal investigator
University of Witten/Herdecke
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Extreme Obesity, run by Prof. Dr. Martin Wabitsch at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI change from baseline (time frame: 1 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.