Altered Liver Function Tests, Glycemic Intolerance, Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-)
Conditions
Keywords
Obalon swallowable intragastric balloons, Severe obesity, Children
Brief summary
The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, switching-on the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity. Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients. Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.
Interventions
DEVICESwallowable Obalon® Gastric Balloon
Sponsors
Bambino Gesù Hospital and Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Weight \> 97° pc -CDC BMI charts-
Exclusion criteria
* Prevous abdominal surgery * Functional gastrointestinal motility disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss (Kg) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 months |
Countries
Italy
Outcome results
None listed