Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

Not Applicable

Completed

• Conditions: Morbid Obesity; NAFLD
• Interventions: Behavioral: Lifestyle Intervention; Procedure: Laparoscopic Sleeve gastrectomy (LSG)

• Registration Number: NCT02564679
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-07
• Status Verified: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-29
• Last Update Submitted: 2015-09-29
• Study First Posted: 2015-10-01
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Intervention	These patients are treated with lifestyle intervention (hypocaloric diet and physical activity)
Sleeve gastrectomy	Laparoscopic Sleeve gastrectomy (LSG)	These patients are surgically treated with laparoscopic sleeve gastrectomy in association to lifestyle intervention (hypocaloric diet and physical activity)

Primary Outcome Measures

Name	Time	Method
Improvement of metabolic parameters	12 months	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)
Improvement of liver parameters	12 months	Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels

Secondary Outcome Measures

Name	Time	Method
Improvement of liver histology	12 months	improvement of liver histology assessed as Non-alcoholic steatohepatitis score (NAS score) in patients treated with sleeve gastrectomy