Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change from Baseline in lipid profile
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis.
Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.
Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent by parents or legal tutor
- •ALT levels <10 ULN
- •hyperechogenicity at liver ultrasound examination suggestive of fatty liver
- •INR < 1,3
- •Albumin > 3 g/dl
- •total bilirubin < 2,5 mg/dl
- •no previous gastrointestinal bleeding
- •no previous portosystemic encephalopathy
- •normal renal function
- •no HIV-HCV-HDV infection
- •normal cell blood count
排除标准
- •every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
- •finding of active liver disease due to other causes
- •corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study
- •alcohol consumption
- •use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- •finding of actual or previous level of alpha-fetoprotein > 50 ng/ml
- •hepatocellular carcinoma
- •diabetes mellitus type I
结局指标
主要结局
Change from Baseline in lipid profile
时间窗: 6,12,18,24 months
Evaluation of tryglicerides, total and LDL colesterol levels
Change from baseline in glycemic homeostasis
时间窗: 6,12,18,24 months
glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test
次要结局
- liver enzymes(6,12,18,24 months)
研究者
Valerio Nobili
Principal Investigator
Bambino Gesù Hospital and Research Institute