Bariatric Surgery in Children.

Obesity, Morbid Clinical Trial

— BASIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01172899
• Other study ID #: NL26279.068.09
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2011
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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

External Links

•   Study website (currently available in Dutch only)