EUCTR2008-006928-55-GB进行中（未招募）不适用
Are early and late cardiovascular risk markers in women with Polycystic Ovary Syndrome increased with concomitant Nonalcoholic Steatohepatitis and can this be modified with Exenatide? - CV risk in PCOS and NASH
Hull and East Yorkshire NHS Trust0 个研究点开始时间: 2009年4月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Polycystic ovary syndrome (defined by the Rotterdam criteria as 2 out of 3 of:
- •1.oligo/anovulation
- •2.clinical or biochemical evidence of hirsuitism, and/or
- •3.polycystic ovaries on ultrasound.
- •Raised alanine aminotransferase
- •Age 16-45 years
- •Patients with confirmed NASH
- •Age 16-45 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Type 2 diabetes
- •Hypothyroidism
- •Subjects taking regular prescribed medication
- •Not using a reliable method on contraception (eg barrier/oral contraceptive pill)
- •Patients not allowing disclosure to their GP’s.
- •History of pancreatitis
- •Chronic renal failure (creatinine clearance less than 60 ml/min or plasma creatinine >150 umol/L)
- •Pregnancy or breastfeeding women
- •Liver function tests >300% reference range normal (eg ALT>90 u/mL)
- •Acute conditions with the potential to alter renal function such as:
- •a.dehydration
- •b.severe infection
- •d.intravascular administration of iodinated contrast
研究者
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Are early and late cardiovascular risk markers in women with Polycystic Ovary Syndrome increased with concomitant Nonalcoholic Steatohepatitis and can this be modified with Liraglutide?Polycystic Ovary Syndrome Non-alcoholic SteatohepatitisMedDRA version: 12.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndromeMedDRA version: 12.0 Level: LLT Classification code 10053219 Term: Non-alcoholic steatohepatitisEUCTR2009-015927-94-GBHull and East Yorkshire NHS Trust
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