Bariatric Surgery in Children.

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.

Conditions

• Obesity, Morbid

Interventions

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.

Sponsors & Collaborators

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• LWE van Heurn, Professor · Maastricht University Medical Center

• Yvonne Roebroek, PhD Student · Maastricht University Medical Center

• Givan F Paulus, PhD Student · Spaarne Gasthuis, Haarlem

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Netherlands

Study Locations