EUCTR2009-015927-94-GB进行中（未招募）1 期
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?
Hull and East Yorkshire NHS Trust0 个研究点目标入组 0 人开始时间: 2010年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
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.
- •and exclusion of other disorders
- •Age 18-45 years
- •Patients with confirmed NASH
- •Age 18-45 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
- •Ketoacidosis
- •Severe gastrointestinal disease
- •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
- •Heart Failure
- •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)
- •Type 2 Diabetes Mellitus
- •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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