Clinical trial NCT01172899: Bariatric Surgery in Children.
Official title: The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Morbid
Keywords: Bariatric Surgery
Adolescent
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 6 months
measure: Weight
timeFrame: 12 months
measure: Weight
timeFrame: 24 months
measure: Weight
timeFrame: 36 months
Secondary outcomes:
measure: Body composition
timeFrame: 12 months
measure: Pubertal development
timeFrame: 6 months
measure: Metabolic and endocrine changes
timeFrame: 6 months
measure: Inflammatory status
timeFrame: 6 months
measure: Cardiovascular abnormalities
timeFrame: 6 months
measure: Non-alcoholic fatty liver disease
timeFrame: 6 months
measure: Quality of life changes
timeFrame: 6 months
measure: Behaviour changes
timeFrame: 6 months
measure: Operative complications
timeFrame: up to 36 months
measure: Effects on sleep architecture
timeFrame: 6 months
measure: Brain development
timeFrame: 6 months
measure: Body composition
timeFrame: 24 months
measure: Body composition
timeFrame: 36 months
measure: Pubertal development
timeFrame: 12 months
measure: Pubertal development
timeFrame: 24 months
measure: Pubertal development
timeFrame: 36 months
measure: Metabolic and endocrine changes
timeFrame: 12 months
measure: Metabolic and endocrine changes
timeFrame: 24 months
measure: Metabolic and endocrine changes
timeFrame: 36 months
measure: Inflammatory status
timeFrame: 12 months
measure: Inflammatory status
timeFrame: 24 months
measure: Inflammatory status
timeFrame: 36 months
measure: Cardiovascular abnormalities
timeFrame: 12 months
measure: Cardiovascular abnormalities
timeFrame: 24 months
measure: Cardiovascular abnormalities
timeFrame: 36 months
measure: Non-alcoholic fatty liver disease
timeFrame: 12 months
measure: Non-alcoholic fatty liver disease
timeFrame: 24 months
measure: Non-alcoholic fatty liver disease
timeFrame: 36 months
measure: Quality of life changes
timeFrame: 12 months
measure: Quality of life changes
timeFrame: 24 months
measure: Quality of life changes
timeFrame: 36 months
measure: Effects on sleep architecture
timeFrame: 12 months
measure: Effects on sleep architecture
timeFrame: 24 months
measure: Effects on sleep architecture
timeFrame: 36 months
measure: Behaviour changes
timeFrame: 12 months
measure: Behaviour changes
timeFrame: 24 months
measure: Behaviour changes
timeFrame: 36 months
measure: Brain development
timeFrame: 12 months
measure: Brain development
timeFrame: 24 months
measure: Brain development
timeFrame: 36 months
measure: Physical activity
timeFrame: 6 months
measure: Physical activity
timeFrame: 12 months
measure: Physical activity
timeFrame: 24
measure: Physical activity
timeFrame: 36 months
measure: Behavior towards food
timeFrame: 6 months
measure: Behavior towards food
timeFrame: 12 months
measure: Behavior towards food
timeFrame: 24 months
measure: Behavior towards food
timeFrame: 36 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: LWE van Heurn, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Yvonne Roebroek, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Spaarne Gasthuis, Haarlem
name: Givan F Paulus, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.