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Trial record 98 of 602 for:    "Obesity, Morbid"

Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

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ClinicalTrials.gov Identifier: NCT02564679
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute

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.


Condition or disease Intervention/treatment Phase
Morbid Obesity NAFLD Procedure: Laparoscopic Sleeve gastrectomy (LSG) Behavioral: Lifestyle Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Sleeve Gastrectomy on Hepatic and Metabolic Abnormalities in Adolescents With Complicated Morbid Obesity and NAFLD
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: Sleeve gastrectomy
These patients are surgically treated with laparoscopic sleeve gastrectomy in association to lifestyle intervention (hypocaloric diet and physical activity)
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.


Experimental: Lifestyle Intervention
These patients are treated with lifestyle intervention (hypocaloric diet and physical activity)
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.





Primary Outcome Measures :
  1. Improvement of metabolic parameters [ Time Frame: 12 months ]
    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)

  2. Improvement of liver parameters [ Time Frame: 12 months ]
    Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels


Secondary Outcome Measures :
  1. Improvement of liver histology [ Time Frame: 12 months ]
    improvement of liver histology assessed as Non-alcoholic steatohepatitis score (NAS score) in patients treated with sleeve gastrectomy



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


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Responsible Party: Valerio Nobili, Professor, Chief of Hepatometabolic Department, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02564679     History of Changes
Other Study ID Numbers: LSG_metabolic profile
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Keywords provided by Valerio Nobili, Bambino Gesù Hospital and Research Institute:
bariatric surgery
sleeve gastrectomy
Additional relevant MeSH terms:
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Obesity, Morbid
Non-alcoholic Fatty Liver Disease
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Fatty Liver
Liver Diseases
Digestive System Diseases