Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Sleeve Gastrectomy on Hepatic and Metabolic Abnormalities in Adolescents With Complicated Morbid Obesity and NAFLD

Conditions
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Morbid Obesity, NAFLD

Intervention / Treatment
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* Procedure: Laparoscopic Sleeve gastrectomy (LSG)
* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleeve gastrectomy<br>These patients are surgically treated with laparoscopic sleeve gastrectomy in association to lifestyle intervention (hypocaloric diet and physical activity) | Procedure: Laparoscopic Sleeve gastrectomy (LSG)<br>* 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.<br>|
| Experimental: Lifestyle Intervention<br>These patients are treated with lifestyle intervention (hypocaloric diet and physical activity) | Behavioral: Lifestyle Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 
| Improvement of liver parameters | Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of liver histology | improvement of liver histology assessed as Non-alcoholic steatohepatitis score (NAS score) in patients treated with sleeve gastrectomy | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, sleeve gastrectomy