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Bariatric Surgery in Children. (BASIC)

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ClinicalTrials.gov Identifier: NCT01172899
Recruitment Status : Active, not recruiting
First Posted : July 30, 2010
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief 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 disease, and impaired quality of life.

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.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: laparoscopic adjustable gastric band Behavioral: Combined life style interventions Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery
Actual Study Start Date : December 1, 2011
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Laparoscopic adjustable gastric band Procedure: laparoscopic adjustable gastric band
Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.

Behavioral: Combined life style interventions
Control group will receive standard therapy consisting of combined lifestyle interventions.
Active Comparator: Control group Behavioral: Combined life style interventions
Control group will receive standard therapy consisting of combined lifestyle interventions.


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: 6 months ]
    Weight loss, excess weight loss and loss of excess BMI.

  2. Weight [ Time Frame: 12 months ]
    Weight loss, excess weight loss and loss of excess BMI.

  3. Weight [ Time Frame: 24 months ]
    Weight loss, excess weight loss and loss of excess BMI.

  4. Weight [ Time Frame: 36 months ]
    Weight loss, excess weight loss and loss of excess BMI.


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 12 months ]
    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.

  2. Pubertal development [ Time Frame: 6 months ]
    Follow-up of hormonal status and Tanner stages.

  3. Metabolic and endocrine changes [ Time Frame: 6 months ]
  4. Inflammatory status [ Time Frame: 6 months ]
    Measurement of serum inflammatory markers.

  5. Cardiovascular abnormalities [ Time Frame: 6 months ]
  6. Non-alcoholic fatty liver disease [ Time Frame: 6 months ]
    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.

  7. Quality of life changes [ Time Frame: 6 months ]
  8. Behaviour changes [ Time Frame: 6 months ]
    Measuring impulsivity and positive reward dominance with a computer task.

  9. Operative complications [ Time Frame: up to 36 months ]
    Early and late complications are being monitored

  10. Effects on sleep architecture [ Time Frame: 6 months ]
  11. Brain development [ Time Frame: 6 months ]
    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.

  12. Body composition [ Time Frame: 24 months ]
    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.

  13. Body composition [ Time Frame: 36 months ]
    Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.

  14. Pubertal development [ Time Frame: 12 months ]
    Follow-up of hormonal status and Tanner stages.

  15. Pubertal development [ Time Frame: 24 months ]
    Follow-up of hormonal status and Tanner stages.

  16. Pubertal development [ Time Frame: 36 months ]
    Follow-up of hormonal status and Tanner stages.

  17. Metabolic and endocrine changes [ Time Frame: 12 months ]
  18. Metabolic and endocrine changes [ Time Frame: 24 months ]
  19. Metabolic and endocrine changes [ Time Frame: 36 months ]
  20. Inflammatory status [ Time Frame: 12 months ]
    Measurement of serum inflammatory markers.

  21. Inflammatory status [ Time Frame: 24 months ]
    Measurement of serum inflammatory markers.

  22. Inflammatory status [ Time Frame: 36 months ]
    Measurement of serum inflammatory markers.

  23. Cardiovascular abnormalities [ Time Frame: 12 months ]
  24. Cardiovascular abnormalities [ Time Frame: 24 months ]
  25. Cardiovascular abnormalities [ Time Frame: 36 months ]
  26. Non-alcoholic fatty liver disease [ Time Frame: 12 months ]
    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.

  27. Non-alcoholic fatty liver disease [ Time Frame: 24 months ]
    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.

  28. Non-alcoholic fatty liver disease [ Time Frame: 36 months ]
    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.

  29. Quality of life changes [ Time Frame: 12 months ]
  30. Quality of life changes [ Time Frame: 24 months ]
  31. Quality of life changes [ Time Frame: 36 months ]
  32. Effects on sleep architecture [ Time Frame: 12 months ]
  33. Effects on sleep architecture [ Time Frame: 24 months ]
  34. Effects on sleep architecture [ Time Frame: 36 months ]
  35. Behaviour changes [ Time Frame: 12 months ]
    Measuring impulsivity and positive reward dominance with a computer task.

  36. Behaviour changes [ Time Frame: 24 months ]
    Measuring impulsivity and positive reward dominance with a computer task.

  37. Behaviour changes [ Time Frame: 36 months ]
    Measuring impulsivity and positive reward dominance with a computer task.

  38. Brain development [ Time Frame: 12 months ]
    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.

  39. Brain development [ Time Frame: 24 months ]
    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.

  40. Brain development [ Time Frame: 36 months ]
    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.

  41. Physical activity [ Time Frame: 6 months ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  42. Physical activity [ Time Frame: 12 months ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  43. Physical activity [ Time Frame: 24 ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  44. Physical activity [ Time Frame: 36 months ]
    Assessment of physical activity using a questionnaire and an accelerometer.

  45. Behavior towards food [ Time Frame: 6 months ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

  46. Behavior towards food [ Time Frame: 12 months ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

  47. Behavior towards food [ Time Frame: 24 months ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.

  48. Behavior towards food [ Time Frame: 36 months ]
    Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172899


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202ZA
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: LWE van Heurn, Professor Maastricht University Medical Center
Principal Investigator: Yvonne Roebroek, PhD Student Maastricht University Medical Center
Principal Investigator: Givan F Paulus, PhD Student Spaarne Gasthuis, Haarlem
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01172899    
Other Study ID Numbers: NL26279.068.09
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Keywords provided by Maastricht University Medical Center:
Bariatric Surgery
Adolescent
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
 Nutrition Disorders
Overweight
Body Weight