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Obesity, MorbidBASICNCT01172899

Bariatric Surgery in Children.

A study testing laparoscopic adjustable gastric band and Combined life style interventions in people with Obesity, Morbid, run by Maastricht University Medical Center at 1 site in Netherlands.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Rationale: In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver… Read more about this study

Who is it for?
Ages 14 to 16 years
Conditions the study is for
Obesity, Morbid
What is being tested?
laparoscopic adjustable gastric band and Combined life style interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteNetherlands
Study dates
1 Dec 2011to Dec 2022
Phase
Interventional
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 14 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Aged 14 to 16
  • Age and sex adjusted BMI >40 kg/m2 or >35 kg/m2 with associated co-morbidity.
  • Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
  • > 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
  • Demonstrate decisional capacity

Who cannot join

  • Psychologically not suitable
  • Pre-menarche or bone age <15 years in boys
  • Obesity associated to other disorders such as hypothyroidism
  • Syndromal disorders such as Prader-Willi syndrome
  • Severe cardiorespiratory impairment (ASA class 3 or higher)
  • Insufficiently fluid in the Dutch language
  • Unwillingness to adhere to follow-up programmes

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht, Limburg, 6202ZA

Other trials in Netherlands

About this study

Official title: The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery

Rationale:

In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.

Read more

The standard treatment for morbid obesity in children is by combined life style interventions. However, the medium and long term effects of dietetic interventions, behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good results with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in this age group is only allowed in clinical trials, until the benefits and risks have been established. (National Health Authorities)

Objective:

To determine if surgery gives a superior weight and body mass index (BMI) reduction than combined life style interventions in adolescents with morbid obesity and to assess its effect on obesity associated co-morbidity.

Study design:

Prospective randomised interventional study.

Study population:

Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI >40 kg/m2 or >35 kg/m2 with co-morbidity.

Intervention:

Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style interventions

Main study parameters/endpoints:

Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary endpoints: Body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain development, quality of life, and behaviour changes. The potential complications of surgery are monitored.

Conditions
Obesity, Morbid
Being tested
laparoscopic adjustable gastric band, Combined life style interventions
Keywords
Bariatric Surgery, Adolescent
Medical subject headings
Obesity, Morbid

What participants receive

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

  • laparoscopic adjustable gastric bandProcedure or surgery

    Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.

  • Combined life style interventionsBehavioural

    Control group will receive standard therapy consisting of combined lifestyle interventions.

Study groups in NCT01172899
Study groupRoleWhat they receive
Laparoscopic adjustable gastric bandExperimentalNot described
Receives: Procedure: laparoscopic adjustable gastric band; Behavioral: Combined life style interventions
Control groupActive comparatorNot described
Receives: Behavioral: Combined life style interventions

What is being measured

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

  1. Weight

    Weight loss, excess weight loss and loss of excess BMI.

    Measured: 6 months

  2. Weight

    Weight loss, excess weight loss and loss of excess BMI.

    Measured: 12 months

  3. Weight

    Weight loss, excess weight loss and loss of excess BMI.

    Measured: 24 months

  4. Weight

    Weight loss, excess weight loss and loss of excess BMI.

    Measured: 36 months

Secondary outcomes (48)

  1. Body composition

    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.

    Measured: 12 months

  2. Pubertal development

    Follow-up of hormonal status and Tanner stages.

    Measured: 6 months

  3. Metabolic and endocrine changes

    Measured: 6 months

  4. Inflammatory status

    Measurement of serum inflammatory markers.

    Measured: 6 months

  5. Cardiovascular abnormalities

    Measured: 6 months

  6. Non-alcoholic fatty liver disease

    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surrogate marker to assess liver disease.

    Measured: 6 months

  7. Quality of life changes

    Measured: 6 months

  8. Behaviour changes

    Measuring impulsivity and positive reward dominance with a computer task.

    Measured: 6 months

  9. Operative complications

    Early and late complications are being monitored

    Measured: up to 36 months

  10. Effects on sleep architecture

    Measured: 6 months

  11. Brain development

    If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.

    Measured: 6 months

  12. Body composition

    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.

    Measured: 24 months

  13. Body composition

    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.

    Measured: 36 months

  14. Pubertal development

    Follow-up of hormonal status and Tanner stages.

    Measured: 12 months

  15. Pubertal development

    Follow-up of hormonal status and Tanner stages.

    Measured: 24 months

  16. Pubertal development

    Follow-up of hormonal status and Tanner stages.

    Measured: 36 months

  17. Metabolic and endocrine changes

    Measured: 12 months

  18. Metabolic and endocrine changes

    Measured: 24 months

  19. Metabolic and endocrine changes

    Measured: 36 months

  20. Inflammatory status

    Measurement of serum inflammatory markers.

    Measured: 12 months

  21. Inflammatory status

    Measurement of serum inflammatory markers.

    Measured: 24 months

  22. Inflammatory status

    Measurement of serum inflammatory markers.

    Measured: 36 months

  23. Cardiovascular abnormalities

    Measured: 12 months

  24. Cardiovascular abnormalities

    Measured: 24 months

  25. Cardiovascular abnormalities

    Measured: 36 months

  26. Non-alcoholic fatty liver disease

    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surrogate marker to assess liver disease.

    Measured: 12 months

  27. Non-alcoholic fatty liver disease

    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surrogate marker to assess liver disease.

    Measured: 24 months

  28. Non-alcoholic fatty liver disease

    Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured. CCL-2 is used as a surrogate marker to assess liver disease.

    Measured: 36 months

  29. Quality of life changes

    Measured: 12 months

  30. Quality of life changes

    Measured: 24 months

  31. Quality of life changes

    Measured: 36 months

  32. Effects on sleep architecture

    Measured: 12 months

  33. Effects on sleep architecture

    Measured: 24 months

  34. Effects on sleep architecture

    Measured: 36 months

  35. Behaviour changes

    Measuring impulsivity and positive reward dominance with a computer task.

    Measured: 12 months

  36. Behaviour changes

    Measuring impulsivity and positive reward dominance with a computer task.

    Measured: 24 months

  37. Behaviour changes

    Measuring impulsivity and positive reward dominance with a computer task.

    Measured: 36 months

  38. Brain development

    If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.

    Measured: 12 months

  39. Brain development

    If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.

    Measured: 24 months

  40. Brain development

    If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.

    Measured: 36 months

  41. Physical activity

    Assessment of physical activity using a questionnaire and an accelerometer.

    Measured: 6 months

  42. Physical activity

    Assessment of physical activity using a questionnaire and an accelerometer.

    Measured: 12 months

  43. Physical activity

    Assessment of physical activity using a questionnaire and an accelerometer.

    Measured: 24

  44. Physical activity

    Assessment of physical activity using a questionnaire and an accelerometer.

    Measured: 36 months

  45. Behavior towards food

    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

    Measured: 6 months

  46. Behavior towards food

    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

    Measured: 12 months

  47. Behavior towards food

    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

    Measured: 24 months

  48. Behavior towards food

    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

    Measured: 36 months

Timeline

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

  1. First posted30 Jul 2010 (estimated)
  2. Study start1 Dec 2011
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01172899
Sponsor's protocol ID
NL26279.068.09
Acronym
BASIC
Status last verified
Aug 2021
First submitted
22 Jul 2010
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Roebroek YGM, Paulus GF, Talib A, van Mil EGAH, Vreugdenhil ACE, Winkens B, Stehouwer CDA, Greve JM, Bouvy ND, van Heurn LWE. Weight Loss and Glycemic Control After Bariatric Surgery in Adolescents With Severe Obesity: A Randomized Controlled Trial. J Adolesc Health. 2024 Mar;74(3):597-604. doi: 10.1016/j.jadohealth.2023.10.024. Epub 2023 Dec 9.

    PubMed 38069930

  • Roebroek YGM, Paulus GF, van Mil EGAH, Vreugdenhil ACE, Winkens B, Nederkoorn C, Stehouwer CDA, Greve JWM, Bouvy ND, van Heurn LWE. Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial). BMC Pediatr. 2019 Jan 28;19(1):34. doi: 10.1186/s12887-019-1395-9.

    PubMed 30691442

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic adjustable gastric band and Combined life style interventions in people with Obesity, Morbid, run by Maastricht University Medical Center at 1 site in Netherlands.

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 5 inclusion and 7 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 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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?

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?

Weight (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT01172899, which also lists 2 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 26 Aug 2021.

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