Effects of Sleeve Gastrectomy on Hepatic and Metabolic Abnormalities in Adolescents With Complicated Morbid Obesity and NAFLD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Improvement of metabolic parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Gastroesophageal reflux disease
- •Severe psychological distress
- •Arthropathies related to weight
排除标准
- •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)
结局指标
主要结局
Improvement of metabolic parameters
时间窗: 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)
Improvement of liver parameters
时间窗: 12 months
Improvement of Aspartate aminotransferases (U/L) and Alanine aminotransferases (U/L) serum levels
次要结局
- Improvement of liver histology(12 months)
研究者
Valerio Nobili
Professor, Chief of Hepatometabolic Department
Bambino Gesù Hospital and Research Institute