Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

Bambino Gesù Hospital and Research Institute

Status: Completed

Conditions: Morbid Obesity; NAFLD

Treatments: Behavioral: Lifestyle Intervention; Procedure: Laparoscopic Sleeve gastrectomy (LSG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02564679

LSG_metabolic profile

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Sleeve gastrectomy

Experimental group

Description:

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

Treatment:

Procedure: Laparoscopic Sleeve gastrectomy (LSG)

Lifestyle Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Intervention