ISRCTN03070108已完成不适用
The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension: A phase IV, randomised controlled trial.
Klinikum Chemnitz gGmbH (Germany)0 个研究点目标入组 72 人开始时间: 2010年3月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female adult patients aged 18 - 70 years inclusive, legally competent
- •2. Written informed consent
- •3. Presence of arterial hypertension
- •4. Evidence of increased Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) >2
- •5. Evidence of decreased Insulin Sensitivity Index (ISI-Matsuda) <4
- •6. Presence of increased liver enzymes
- •6.1. Alanine transaminase (ALT)
- •6.2. Gamma-glytamyl transpeptidase (gamma-GT)
- •7. Presence of fatty liver indicated by sonography
- •8. Ethnic background: caucasian
- •9. Presence of negative pregnancy test
排除标准
- •1. Other liver diseases: e.g. virus-induced hepatitis, hemochromatosis
- •2. Presence of severe increased liver enzymes as an evidence for serious liver diseases
- •2.1. ALT > 4 µkat/l
- •2.2. Aspartate Aminotransferase (AST) > 4 µkat/l
- •2.3. Gamma-GT > 10 µkat/l
- •3. Increased AST enzyme activity in comparison to ALT enzyme activity as an evidence for an alcoholic fatty liver disease (AFLD)
- •4. Obstructive disease of bile ducts and cholestasis
- •5. Pre-treatment of hypertension with sartans
- •6. Chronic infections with increased C-Reactive Protein (CRP) serum concentration
- •7. Hypersensitivity to telmisartan or another ingredient of medicinal product
- •8. Hereditary fructose intolerance based on sorbitol in medicinal product
- •9. Presence of an angioneurotic oedema during former treatment with ACE-inhibitors or angiotensin-II-receptor-antagonists
- •10. Presence of manifest diabetes mellitus type 2
- •11. Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
- •12. Pregnancy, lactation period or female patients seeking to become pregnant during interventional period
- •13. Low compliance or inability to understand instructions/study documents
研究者
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