Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

NCT02564679 | Completed

• 1 other identifier: LSG_metabolic profile
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Morbid Obesity; NAFLD

Keywords

bariatric surgery; sleeve gastrectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Improvement of liver histology

  12 months

Study Arms (2)

Sleeve gastrectomy

EXPERIMENTAL

These patients are surgically treated with laparoscopic sleeve gastrectomy in association to lifestyle intervention (hypocaloric diet and physical activity)

Procedure: Laparoscopic Sleeve gastrectomy (LSG)

Lifestyle Intervention

EXPERIMENTAL

These patients are treated with lifestyle intervention (hypocaloric diet and physical activity)

Behavioral: Lifestyle Intervention

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.

Sleeve gastrectomy

Lifestyle Intervention BEHAVIORAL

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

MeSH Terms

Conditions

Obesity, Morbid; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Hepatometabolic Department

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 1, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-09