Bariatric Surgery in Children.
- Conditions
- Obesity, Morbid
- Interventions
- Procedure: laparoscopic adjustable gastric bandBehavioral: Combined life style interventions
- Registration Number
- NCT01172899
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic adjustable gastric band laparoscopic adjustable gastric band - Laparoscopic adjustable gastric band Combined life style interventions - Control group Combined life style interventions -
- Primary Outcome Measures
Name Time Method Weight 36 months Weight loss, excess weight loss and loss of excess BMI.
- Secondary Outcome Measures
Name Time Method Metabolic and endocrine changes 36 months Quality of life changes 36 months Behaviour changes 36 months Measuring impulsivity and positive reward dominance with a computer task.
Behavior towards food 36 months Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
Effects on sleep architecture 36 months Body composition 36 months Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
Non-alcoholic fatty liver disease 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.
Pubertal development 36 months Follow-up of hormonal status and Tanner stages.
Inflammatory status 36 months Measurement of serum inflammatory markers.
Cardiovascular abnormalities 36 months Operative complications up to 36 months Early and late complications are being monitored
Brain development 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.
Physical activity 36 months Assessment of physical activity using a questionnaire and an accelerometer.
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands