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临床试验/NCT00483392
NCT00483392已完成不适用

Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家开始时间: 2007年6月7日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
试验地点
2
主要终点
fasting plasma glucose, basal insulin levels

研究概览

简要总结

The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks.

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 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • documented HIV infection
  • stable Protease Inhibitor containing HAART regimen for at least 12 months
  • impaired glucose tolerance
  • elevated insulin levels (above 20 mIU/l)

排除标准

  • patients already taking oral hypoglycaemic treatment or insulin
  • heart failure NYHA I-IV
  • liver disease or kidney disease
  • elevated AST or ALT above 2 times upper normal range
  • elevated creatinine (above 150 mmol/l)

结局指标

主要结局

fasting plasma glucose, basal insulin levels

时间窗: 48 weeks

次要结局

  • insulin resistance, beta cell function(48 week)

研究者

申办方类型
Other

研究点 (2)

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