Efficacy of Phosphatidylcholine in Addition to Behavior Therapy by Clinical Pharmacist in the Management of Non Alcoholic Fatty Liver (NAFLD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- change from baseline Body Mass Index (BMI) at 3 and 6 month
研究概览
简要总结
This study evaluates efficacy of Phosphatidylcholine in addition to life style modification and patient health education by clinical Pharmacist in the Management of Non Alcoholic Fatty Liver NAFLD. All participants with NAFLD will receive life style intervention and half of them will receive additionally Phosphatidylcholine.
详细描述
As a result of increasing rates of obesity Non Alcoholic Fatty Liver (NAFLD) is the most common liver disorder affecting 17-46% of adults and parallels the prevalence of Metabolic Syndrome (MetS) and its components which also increases the risk of more advanced disease both in adults and in children.
Its pathogenesis is complex and multifactorial, mainly involving genetic, environmental and metabolic factors. New concepts are constantly appearing in the literature, promising new diagnostic and therapeutic tools. Further studies are needed to better characterize not only NAFLD development but overall NAFLD progression, in order to better identify NAFLD patients at higher risk of metabolic, cardiovascular and neoplastic complications. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven Nonalcoholic steatohepatitis (NASH) and liver fibrosis. Not much therapeutic options for NAFLD are accepted until today besides correction of obesity with hypocaloric diets and physical exercise and controlling hyperglycemia with diet, insulin, or oral hypoglycemic agents. Weight loss generally reduces hepatic steatosis.Essential phospholipid (EPL) as a nutritional supplement is one of the drugs under discussion with significant positive effects as antioxidative, antifibrotic effects and high biocompatibility on NAFLD.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fatty liver upon Ultrasonography (US) /Computed Tomography (CT) /Magnetic Resonance Imaging (MRI) with either incidental increased Alanine Aminotransferase (ALT)
- •the presence of risk factors related to NAFLD + increased ALT
- •symptomatic liver disease +/- hepatomegaly, +/- increased ALT
- •homeostasis model assessment-insulin resistance HOMA IR score > 3
- •presence of liver steatosis or stiffness measured by transient elastography
- •eligible patients had at least one of the following metabolic comorbidities: hypertension, Type 2 Diabetes Mellitus, overweight/obesity (BMI>27 kg/m2) serum cholesterol of > 200 mg/d
- •Patients were excluded from the study if showing evidence :
排除标准
- •if showing evidence of alcoholic or chronic liver disease
- •Hepatocellular Carcinoma, autoimmune hepatitis
- •end stage liver disease
- •treatment with other hepatoprotectants
- •other concomitant EPL within 30 days of study initiation
- •pregnancy or lactation
结局指标
主要结局
change from baseline Body Mass Index (BMI) at 3 and 6 month
时间窗: baseline, at 3 and 6 month
person's weight in kilograms divided by the square of the person's height in metres (kg/m2).
change from baseline liver stiffness at 3 and 6 month
时间窗: baseline , at 3 and 6 month
Liver Stiffness and fibrosis score measured by Transient elastography (Fibroscan) F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis
change from baseline Lipid Profile
时间窗: baseline , at 3 and 6 month
Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein
change from baseline Oxidative stress markers
时间窗: baseline , at 3 and 6 month
malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay
change from baseline NAFLD score at 3 and 6 month
时间窗: baseline , at 3 and 6 month
NAFLD Fibrosis Score is based on six readily available variables (age, BMI, hyperglycemia, albumin, platelet count, AST/ALT ratio) and it is calculated using published formula (http: //naflds- core.com) . A low cutpoint (score \< -1.455) signified the absence of advanced fibrosis, whereas a high cutpoint (score\> 0.676) identified advanced fibrosis.
change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month
时间窗: baseline , at 3 and 6 month
HOMA IR scores \<3 normal HOMA IR scores \>5 severe insulin resistance 3 to 5 moderate insulin resistance
次要结局
- change from baseline Complete Blood Picture at 3 and 6 month(baseline , at 3 and 6 month)
研究者
Nehal Abou Seada
Principal Investigator
Ain Shams University