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临床试验/NCT01617772
NCT01617772Unknown2 期

Comparison the Effectiveness of L-Carnitine With Atorvastatin in Non-Alcoholic Steatohepatitis (NASH)

Tehran University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
440
试验地点
2
主要终点
improvement in liver stiffness

研究概览

简要总结

The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver elasticity in NASH patients.

详细描述

Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of disease ranging from steatosis to steatohepatitis (nonalcoholic steatohepatitis, NASH) to cirrhosis. Statins are competitive inhibitors of Hydroxymethylglutaryl-CoA reductase, the rate-limiting step in cholesterol biosynthesis. They occupy a portion of the binding site of Hydroxymethylglutaryl-CoA, blocking access of this substrate to the active site on the enzyme. A reduction in intrahepatic cholesterol leads to an increase in LDL receptor turnover that results from an enhanced rate of hepatic LDL receptor cycling. On the other hand recent studies have implicated several important cellular processes and signaling pathways that are affected by abnormal lipid metabolism, resulting in specific biochemical, histological, and clinical changes associated with NAFLD.

Maybe statins, as lipid lowering agents, and through their effect in reduction of intrahepatic cholesterol, can affect the abnormal lipid metabolism in NASH.

L- carnitine, can improve the outcome of NASH, because it reduces lipid levels, limits oxidative stress, and modulates inflammatory responses . It performs a number of essential intracellular and metabolic functions, such as fatty acid transport, detoxification of potentially toxic metabolites, regulation of the mitochondrial acyl-CoA / CoA ratio, and stabilization of cell membranes. It has a pivotal role in the transport of long chain fatty acids across the inner mitochondrial membrane.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • NASH diagnosed on the basis of the following criteria:
  • Imaging techniques showing evidence of hepatic steatosis
  • Increased alanine transaminase above 1.5 times normal (normal: 20 IU/L for women, 30 for men) on two occasions three months apart.

排除标准

  • Patients with hepatitis B or C
  • alanine transaminase > 300 IU/L
  • Participants presenting one or more causes commonly associated with secondary NAFLD (drugs, surgical procedures, environmental toxins, or total parenteral nutrition)
  • Alcohol ingestion greater than 40 gr per week
  • Abnormal Lipid profile (TG>500 , LDL>160)
  • Patients with hypertension, diabetes mellitus, coronary heart disease
  • Fibroscan score more than 14 kp
  • pregnancy, lactation
  • Drug addiction
  • Reynolds Risk Score > 10%
  • Not consenting to the study

研究组 & 干预措施

Atorvastatin

Experimental

20mg atorvastatin daily

干预措施: Atorvastatin (Drug)

Carnitine

Experimental

1000mg L-carnitine daily

干预措施: L-Carnitine (Drug)

Atoral

Experimental

1000mg L-carnitine and 20mg atorvastatin

干预措施: Atorvastatin (Drug)

Atoral

Experimental

1000mg L-carnitine and 20mg atorvastatin

干预措施: L-Carnitine (Drug)

Placebo

Placebo Comparator

Identically looking placebo

干预措施: Placebo (Drug)

结局指标

主要结局

improvement in liver stiffness

时间窗: 2 years

As measured by Fibroscan

次要结局

  • improvement in liver enzyme levels(2 years)
  • Adverse drug events(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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