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临床试验/ACTRN12608000448347
ACTRN12608000448347已完成未知

Impact of Iron on Insulin Resistance and liver histology in non-alcoholic steatohepatitis.

Raines Medical Research Foundation0 个研究点目标入组 80 人开始时间: 2008年9月12日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • Biopsy demonstrating NASH within six months of trial entry.

排除标准

  • Unable to provide informed consent
  • Ischemic heart disease
  • Pregnancy or lactation
  • Ferritin <50 ug/L
  • Venesection in the previous 12 months prior to trial entry
  • Other causes of liver disease: positive hepatitis B serology, positive hepatitis C serology, auto-antibodies, alpha-one anti-trypsin level and ceruloplasmin.
  • Acute or chronic inflammatory con ditions
  • Hereditary hemochromatosis (C282Y/C282Y or C282Y/H63D HFE gene mutation)
  • Alcohol consumption >20 grams/dat for males, >10 grams/day for females
  • Secondary causes of NAFLD (corticosteroids, gastro-intestinal bypass)
  • Use of anti-oxidants (vitamin E or C) or anti-TNF agents (pentoxifylline)
  • Poor glycaemic control diabetic (HbA1c>8.0%)
  • Decompensated cirrhosis INR(international normalized ratio)>1.3, albumin <35mg/dl or bilirubin >20 mmol/l or ascites or hepatic encephalopathy
  • Bleeding tendency precluding a repeat liver biopsy
  • Malignancy( excluding basal cell or squamous cell skin cancers)

研究者

发起方
Raines Medical Research Foundation

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