Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

NCT ID: NCT02564679

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleeve gastrectomy

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

Group Type: EXPERIMENTAL

Laparoscopic Sleeve gastrectomy (LSG)

Intervention Type: 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 Intervention

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

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Valerio Nobili

Professor, Chief of Hepatometabolic Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LSG_metabolic profile

Identifier Type: -

Identifier Source: org_study_id