An interventional study of laparoscopic adjustable gastric band and Combined life style interventions in Obesity, Morbid, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 14 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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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.
Exclusion Criteria:
Procedure: laparoscopic adjustable gastric band · Behavioral: Combined life style interventions
Behavioral: Combined life style interventions
Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.
Control group will receive standard therapy consisting of combined lifestyle interventions.
Weight
Weight loss, excess weight loss and loss of excess BMI.
Time frame: 6 months
Weight
Weight loss, excess weight loss and loss of excess BMI.
Time frame: 12 months
Weight
Weight loss, excess weight loss and loss of excess BMI.
Time frame: 24 months
Weight
Weight loss, excess weight loss and loss of excess BMI.
Time frame: 36 months
Body composition
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
Time frame: 12 months
Pubertal development
Follow-up of hormonal status and Tanner stages.
Time frame: 6 months
Metabolic and endocrine changes
Time frame: 6 months
Inflammatory status
Measurement of serum inflammatory markers.
Time frame: 6 months
Cardiovascular abnormalities
Time frame: 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.
Time frame: 6 months
Quality of life changes
Time frame: 6 months
Behaviour changes
Measuring impulsivity and positive reward dominance with a computer task.
Time frame: 6 months
Operative complications
Early and late complications are being monitored
Time frame: up to 36 months
Effects on sleep architecture
Time frame: 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.
Time frame: 6 months
Body composition
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
Time frame: 24 months
Body composition
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
Time frame: 36 months
Pubertal development
Follow-up of hormonal status and Tanner stages.
Time frame: 12 months
Pubertal development
Follow-up of hormonal status and Tanner stages.
Time frame: 24 months
Pubertal development
Follow-up of hormonal status and Tanner stages.
Time frame: 36 months
Metabolic and endocrine changes
Time frame: 12 months
Metabolic and endocrine changes
Time frame: 24 months
Metabolic and endocrine changes
Time frame: 36 months
Inflammatory status
Measurement of serum inflammatory markers.
Time frame: 12 months
Inflammatory status
Measurement of serum inflammatory markers.
Time frame: 24 months
Inflammatory status
Measurement of serum inflammatory markers.
Time frame: 36 months
Cardiovascular abnormalities
Time frame: 12 months
Cardiovascular abnormalities
Time frame: 24 months
Cardiovascular abnormalities
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 36 months
Quality of life changes
Time frame: 12 months
Quality of life changes
Time frame: 24 months
Quality of life changes
Time frame: 36 months
Effects on sleep architecture
Time frame: 12 months
Effects on sleep architecture
Time frame: 24 months
Effects on sleep architecture
Time frame: 36 months
Behaviour changes
Measuring impulsivity and positive reward dominance with a computer task.
Time frame: 12 months
Behaviour changes
Measuring impulsivity and positive reward dominance with a computer task.
Time frame: 24 months
Behaviour changes
Measuring impulsivity and positive reward dominance with a computer task.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 36 months
Physical activity
Assessment of physical activity using a questionnaire and an accelerometer.
Time frame: 6 months
Physical activity
Assessment of physical activity using a questionnaire and an accelerometer.
Time frame: 12 months
Physical activity
Assessment of physical activity using a questionnaire and an accelerometer.
Time frame: 24
Physical activity
Assessment of physical activity using a questionnaire and an accelerometer.
Time frame: 36 months
Behavior towards food
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
Time frame: 6 months
Behavior towards food
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
Time frame: 12 months
Behavior towards food
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
Time frame: 24 months
Behavior towards food
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
Time frame: 36 months
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center