Bariatric Surgery in Children. (BASIC)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: laparoscopic adjustable gastric band; Behavioral: Combined life style interventions

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202ZA
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Behavioral: Combined life style interventions; Control group will receive standard therapy consisting of combined lifestyle interventions.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: 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

Publications and helpful links

General Publications

• Roebroek YGM, Paulus GF, van Mil EGAH, Vreugdenhil ACE, Winkens B, Nederkoorn C, Stehouwer CDA, Greve JWM, Bouvy ND, van Heurn LWE. Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial). BMC Pediatr. 2019 Jan 28;19(1):34. doi: 10.1186/s12887-019-1395-9.

Helpful Links

• Study website (currently available in Dutch only)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Adolescent; Bariatric Surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: NL26279.068.09