Bariatric Surgery in Children.

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: laparoscopic adjustable gastric band
* Behavioral: Combined life style interventions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic adjustable gastric band<br> | Procedure: laparoscopic adjustable gastric band<br>* Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.<br>Behavioral: Combined life style interventions<br>* Control group will receive standard therapy consisting of combined lifestyle interventions.<br>|
| Active Comparator: Control group<br> | Behavioral: Combined life style interventions<br>* Control group will receive standard therapy consisting of combined lifestyle interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight loss, excess weight loss and loss of excess BMI. | 6 months | 
| Weight | Weight loss, excess weight loss and loss of excess BMI. | 12 months | 
| Weight | Weight loss, excess weight loss and loss of excess BMI. | 24 months | 
| Weight | Weight loss, excess weight loss and loss of excess BMI. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed. | 12 months | 
| Pubertal development | Follow-up of hormonal status and Tanner stages. | 6 months | 
| Metabolic and endocrine changes |  | 6 months | 
| Inflammatory status | Measurement of serum inflammatory markers. | 6 months | 
| Cardiovascular abnormalities |  | 6 months | 
| 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. | 6 months | 
| Quality of life changes |  | 6 months | 
| Behaviour changes | Measuring impulsivity and positive reward dominance with a computer task. | 6 months | 
| Operative complications | Early and late complications are being monitored | up to 36 months | 
| Effects on sleep architecture |  | 6 months | 
| 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. | 6 months | 
| Body composition | Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed. | 24 months | 
| Body composition | Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed. | 36 months | 
| Pubertal development | Follow-up of hormonal status and Tanner stages. | 12 months | 
| Pubertal development | Follow-up of hormonal status and Tanner stages. | 24 months | 
| Pubertal development | Follow-up of hormonal status and Tanner stages. | 36 months | 
| Metabolic and endocrine changes |  | 12 months | 
| Metabolic and endocrine changes |  | 24 months | 
| Metabolic and endocrine changes |  | 36 months | 
| Inflammatory status | Measurement of serum inflammatory markers. | 12 months | 
| Inflammatory status | Measurement of serum inflammatory markers. | 24 months | 
| Inflammatory status | Measurement of serum inflammatory markers. | 36 months | 
| Cardiovascular abnormalities |  | 12 months | 
| Cardiovascular abnormalities |  | 24 months | 
| Cardiovascular abnormalities |  | 36 months | 
| 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. | 12 months | 
| 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. | 24 months | 
| 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. | 36 months | 
| Quality of life changes |  | 12 months | 
| Quality of life changes |  | 24 months | 
| Quality of life changes |  | 36 months | 
| Effects on sleep architecture |  | 12 months | 
| Effects on sleep architecture |  | 24 months | 
| Effects on sleep architecture |  | 36 months | 
| Behaviour changes | Measuring impulsivity and positive reward dominance with a computer task. | 12 months | 
| Behaviour changes | Measuring impulsivity and positive reward dominance with a computer task. | 24 months | 
| Behaviour changes | Measuring impulsivity and positive reward dominance with a computer task. | 36 months | 
| 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. | 12 months | 
| 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. | 24 months | 
| 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. | 36 months | 
| Physical activity | Assessment of physical activity using a questionnaire and an accelerometer. | 6 months | 
| Physical activity | Assessment of physical activity using a questionnaire and an accelerometer. | 12 months | 
| Physical activity | Assessment of physical activity using a questionnaire and an accelerometer. | 24 | 
| Physical activity | Assessment of physical activity using a questionnaire and an accelerometer. | 36 months | 
| Behavior towards food | Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food. | 6 months | 
| Behavior towards food | Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food. | 12 months | 
| Behavior towards food | Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food. | 24 months | 
| Behavior towards food | Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery, Adolescent