Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

Bambino Gesù Hospital and Research Institute40 enrolled

Overview

Pediatric obesity has become a critical health problem worldwide, increasing the premature onset of obesity-related morbidities. This phenomenon has induce an increase in the incidence of serious health complications starting in childhood and adolescence. Lifestyle interventions, including diet and regular physical activity, are the cornerstone of current medical management. Unfortunately, these interventions are often ineffective in providing a meaningful and long-lasting weight loss necessary to change health outcomes. It has been demonstrated that an early intervention in obesity in children and adolescents, inducing weight loss by performing bariatric surgery in carefully selected patients, can dramatically reduce the risk of adulthood obesity and obesity-related diseases, including non-alcoholic fatty liver disease (NAFLD). Recent evidence suggest that bariatric surgery can improve metabolic complications and liver involvement in patients affected by morbid obesity.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Morbid Obesity NAFLD

Interventions

Laparoscopic Sleeve gastrectomy (LSG)PROCEDURE

These patients (no. 20) are assessed by clinical and psychological evaluation (auxological parameters, blood pressure and personal and family history), blood tests (liver function test's (LFT's), uric acid, lipid and gluco-insulinemic profile with oral glucose tolerance test (OGTT)), abdominal ultrasound at time of enrollment. They are treated with laparoscopic sleeve gastrectomy associated to lifestyle intervention. Concomitantly to surgical intervention, liver biopsy is performed. At 6 and 12 months after LSG the patients are evaluated with laboratory, clinical and echographic assessment. Moreover, one year after LSG liver biopsy is repeated.

Lifestyle InterventionBEHAVIORAL

These patients (no. 20) are assessed by clinical and psychological evaluation (auxological parameters, blood pressure and personal and family history), blood tests (liver function test's (LFT's), uric acid, lipid and gluco-insulinemic profile with oral glucose tolerance test (OGTT)), abdominal ultrasound at time of enrollment. They are treated with lifestyle intervention. At 6 and 12 months after enrollment the patients are evaluated with laboratory, clinical and echographic assessment.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion criteria: * BMI\>40 kg/m2 with severe comorbidities * Type 2 diabetes mellitus * Moderate-to-severe sleep apnea * Pseudotumor cerebri * NASH with advanced fibrosis (ISHAK score\>1) * BMI\>50 kg/m2 with mild comorbidities * Hypertension * Dyslipidemia * Mild obstructive sleep apnea * Chronic venous insufficiency * Panniculitis * Urinary incontinence * Impairment in activities of daily living * NASH * Gastroesophageal reflux disease * Severe psychological distress * Arthropathies related to weight Exclusion Criteria: * Documented substance abuse problem * Medically correctable cause of obesity * Disability that would impair adherence to postoperative treatment, present pregnancy, or breast-feeding The patients included in the present study were enrolled according to the recent indications for bariatric surgery in severly obese adolescents of Hepatology Committee of European Society of Pediatric Gastroenterology, Hepatology And Nutrition (ESPGHAN) (JPGN 2015;60: 550-561)

Outcomes

Primary Outcomes

Improvement of metabolic parameters

Improvement of serum levels of cholesterol (mg/dl), triglycerides (mg/dl), HDL (mg/dl), LDL (mg/dl), uric acid (mg/dl), and gluco-insulinemic profile (serum concentration during standard oral glucose tolerance test - OGTT)

Time frame: 12 months

Improvement of liver parameters

Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels

Time frame: 12 months

Secondary Outcomes

Improvement of liver histology

improvement of liver histology assessed as Non-alcoholic steatohepatitis score (NAS score) in patients treated with sleeve gastrectomy

Time frame: 12 months