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BASIC trial

LAGB treatment vs. lifestyle interventions in adolescents

Study to determine whether combining LAGB with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction vs. lifestyle interventions only

Researchers from The Netherlands have begun the Bariatric Surgery in Children (BASIC) randomised controlled trial that will assess the safety and efficacy of laparoscopic adjustable gastric banding (LAGB) treatment in severely obese adolescents with unsuccessful combined lifestyle interventions (CLI). The authors note that the reversibility of LAGB is a strong argument for gastric banding over other surgical procedures, since bariatric surgery in adolescents is still in its infancy.

The study outline paper, ‘Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial)’, published in BMC Pediatrics, is seeking to determine whether combining LAGB with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction vs. lifestyle interventions only. In addition, the trial will also assess its effect on obesity-associated co-morbidities.

The study plans to recruit 60 adolescent patients with severe obesity (30 in each group) aged 14–16 years with sex- and age-adjusted BMI>40 (or >35  with comorbidity/ies) and failure to achieve weight reduction >5% during at least one year of combined lifestyle interventions. Follow-up visits are scheduled at six months, one, two and three years. Primary endpoints include the percentage of total weight loss and change of BMI. Secondary endpoints include body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, quality of life and changes in behaviour. The trial will be carried out at the Maastricht University Medical Centre in the Netherlands. The flowchart of the BASIC trial study design is shown in Figure 1.

Figure 1: Flowchart of the BASIC trial study design

All patients participating in the trial will receive lifestyle interventions and follow-up throughout the entire trial period, and will return to the paediatrician, dietician and psychologist of the referring obesity clinic for continuation of the lifestyle programme.

The researchers believe that this is the first randomised controlled trial investigating bariatric surgery as a complementary treatment in adolescents with failed combined lifestyle interventions.

“The unique control group will provide a necessary framework of data regarding physiological changes throughout adolescence and pathophysiological effects of persistent childhood severe obesity,” the authors conclude. “The results of this study may steer the international opinion regarding treatment options of severely obese adolescents who still have most of their lives ahead of them.”

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