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Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

Primary Purpose

Morbid Obesity, NAFLD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Sleeve gastrectomy (LSG)
Lifestyle Intervention
Sponsored by
Bambino Gesù Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring bariatric surgery, sleeve gastrectomy

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sleeve gastrectomy

    Lifestyle Intervention

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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)
    Improvement of liver parameters
    Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels

    Secondary Outcome Measures

    Improvement of liver histology
    improvement of liver histology assessed as Non-alcoholic steatohepatitis score (NAS score) in patients treated with sleeve gastrectomy

    Full Information

    First Posted
    September 23, 2015
    Last Updated
    September 29, 2015
    Sponsor
    Bambino Gesù Hospital and Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02564679
    Brief Title
    Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD
    Official Title
    Effects of Sleeve Gastrectomy on Hepatic and Metabolic Abnormalities in Adolescents With Complicated Morbid Obesity and NAFLD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bambino Gesù Hospital and Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity, NAFLD
    Keywords
    bariatric surgery, sleeve gastrectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sleeve gastrectomy
    Arm Type
    Experimental
    Arm Description
    These patients are surgically treated with laparoscopic sleeve gastrectomy in association to lifestyle intervention (hypocaloric diet and physical activity)
    Arm Title
    Lifestyle Intervention
    Arm Type
    Experimental
    Arm Description
    These patients are treated with lifestyle intervention (hypocaloric diet and physical activity)
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Sleeve gastrectomy (LSG)
    Intervention Description
    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
    Behavioral
    Intervention Name(s)
    Lifestyle Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Improvement of metabolic parameters
    Description
    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)
    Time Frame
    12 months
    Title
    Improvement of liver parameters
    Description
    Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Improvement of liver histology
    Description
    improvement of liver histology assessed as Non-alcoholic steatohepatitis score (NAS score) in patients treated with sleeve gastrectomy
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

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    Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

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