Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

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

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 Overview

• Status: Completed
• Conditions: NAFLD; Morbid Obesity
• Intervention / Treatment: Procedure: Laparoscopic Sleeve gastrectomy (LSG); Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bambino Gesù Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: bariatric surgery; sleeve gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Fatty Liver; Obesity; Non-alcoholic Fatty Liver Disease; Obesity, Morbid
• Other Study ID Numbers: LSG_metabolic profile

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No