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ObesityPhase 3NCT00289705

Surgical Intervention for Morbidly Obese Adolescents

A Phase 3 study testing Surgery in people with Obesity and Diabetes, run by Göteborg University at 4 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated. Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Obesity, Diabetes, Hypertension
What is being tested?
Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
4 sitesSweden
Study dates
Feb 2006to Feb 2018
Phase
Phase 3
Are there results?
None posted in the registry

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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • BMI >40 kg/m2 or BMI>35 with comorbidity
  • Pass psychological evaluation
  • Puberty status Tanner 4-5
  • At least one year with active conservative treatment that failed

Who cannot join

  • Lack of compliance
  • Specific obesity syndrome as Praeder Willis
  • Obesity due to brain injury
  • Severe general disease
  • Specific genetic defect (MC4R, Leptin deficiency)

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Sahlgrenska University Hospital, Dept of Surgery

    Gothenburg, Gothenburg, 41345

  • Queen Silvias Children Hospital

    Gothenburg, Göteborg

  • Dept of Pediatrics, MAS

    Malmö, Malmö

  • National center for child obesity, Karolinska Huddinge

    Stockholm, Stockholm County, 14186

Other trials in Sweden

About this study

Official title: Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study

The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.

Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.

Read the detailed description

Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI >40kg/m2 in the adolescence will remain morbidly obese also in their adult life.

The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.

Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.

Being tested
Surgery
Keywords
Obesity, Surgery, Adolescent, Roux-en-Y gastric bypass, Laparoscopic
Medical subject headings
Obesity, Diabetes Mellitus, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Laparoscopic Roux-en-Y gastric bypass

Study groups in NCT00289705
Study groupRoleWhat they receive
SurgeryExperimentalLaparoscopic gastric bypass
Receives: Procedure: Surgery
2No interventionTraditional treatment for obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI development

    Measured: 10 years

Secondary outcomes (1)

  1. Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionNov 2017 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00289705
Sponsor's protocol ID
SU523-04
Status last verified
Feb 2017
First submitted
9 Feb 2006
Last updated
2 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Jarvholm K, Olbers T, Peltonen M, Marcus C, Flodmark CE, Gronowitz E, Dahlgren J, Karlsson J. Depression, anxiety, and suicidal ideation in young adults 5 years after undergoing bariatric surgery as adolescents. Eat Weight Disord. 2021 May;26(4):1211-1221. doi: 10.1007/s40519-020-01024-0. Epub 2020 Oct 20.

    PubMed 33079376

  • Jarvholm K, Bruze G, Peltonen M, Marcus C, Flodmark CE, Henfridsson P, Beamish AJ, Gronowitz E, Dahlgren J, Karlsson J, Olbers T. 5-year mental health and eating pattern outcomes following bariatric surgery in adolescents: a prospective cohort study. Lancet Child Adolesc Health. 2020 Mar;4(3):210-219. doi: 10.1016/S2352-4642(20)30024-9. Epub 2020 Jan 21.

    PubMed 31978372

  • Olbers T, Beamish AJ, Gronowitz E, Flodmark CE, Dahlgren J, Bruze G, Ekbom K, Friberg P, Gothberg G, Jarvholm K, Karlsson J, Marild S, Neovius M, Peltonen M, Marcus C. Laparoscopic Roux-en-Y gastric bypass in adolescents with severe obesity (AMOS): a prospective, 5-year, Swedish nationwide study. Lancet Diabetes Endocrinol. 2017 Mar;5(3):174-183. doi: 10.1016/S2213-8587(16)30424-7. Epub 2017 Jan 6.

    PubMed 28065734

  • Beamish AJ, Gronowitz E, Olbers T, Flodmark CE, Marcus C, Dahlgren J. Body composition and bone health in adolescents after Roux-en-Y gastric bypass for severe obesity. Pediatr Obes. 2017 Jun;12(3):239-246. doi: 10.1111/ijpo.12134. Epub 2016 Apr 12.

    PubMed 27071497

  • Gothberg G, Gronowitz E, Flodmark CE, Dahlgren J, Ekbom K, Marild S, Marcus C, Olbers T. Laparoscopic Roux-en-Y gastric bypass in adolescents with morbid obesity--surgical aspects and clinical outcome. Semin Pediatr Surg. 2014 Feb;23(1):11-6. doi: 10.1053/j.sempedsurg.2013.10.015. Epub 2013 Nov 15.

    PubMed 24491362

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Surgery in people with Obesity and Diabetes, run by Göteborg University at 4 sites in Sweden.

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 4 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: status not confirmed, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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 development (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289705, which also lists 5 linked publications.

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 2 Feb 2017.

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