Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564679
• Other study ID #: LSG_metabolic profile
• Status: Completed
• Phase: N/A
• First received: September 23, 2015
• Last updated: September 29, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• NAFLD
• Obesity
• Obesity, Morbid

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Improvement of liver parameters	Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels	12 months	No
Secondary	Improvement of liver histology	improvement of liver histology assessed as Non-alcoholic steatohepatitis score (NAS score) in patients treated with sleeve gastrectomy	12 months	No