ISRCTN81902209已完成未知
Are early and late cardiovascular risk markers in women with polycystic ovary syndrome (PCOS) increased with concomitant non-alcoholic steatohepatitis (NASH) and can this be modified with exenatide?: An interventional open parallel single-centre trial
Hull and East Yorkshire Hospitals NHS Trust (UK)0 个研究点目标入组 20 人开始时间: 2009年5月13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
- 20
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31001199 [added 26/04/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Polycystic ovary syndrome (defined by the Rotterdam criteria as 2 out of 3 of:
- •1.1. Oligo/anovulation
- •1.2. Clinical or biochemical evidence of hirsuitism, and/or
- •1.3. Polycystic ovaries on ultrasound
- •2. Raised alanine aminotransferase (ALT)
- •3. Female, age 16-45 years
- •1. Patients with confirmed NASH
- •3. Age 16-45 years
排除标准
- •1. Ketoacidosis
- •2. Severe gastrointestinal disease
- •3. Type 2 diabetes
- •4. Hypothyroidism
- •5. Subjects taking regular prescribed medication
- •6. Not using a reliable method on contraception (eg barrier/oral contraceptive pill)
- •7. Patients not allowing disclosure to their GP's
- •8. History of pancreatitis
- •9. Chronic renal failure (creatinine clearance less than 60 ml/min or plasma creatinine >150 umol/L)
- •10. Pregnancy or breastfeeding women
- •11. Liver function tests >300% reference range normal (e.g., ALT >90 u/mL)
- •12. Acute conditions with the potential to alter renal function such as:
- •12.1. Dehydration
- •12.2. Severe infection
- •12.3. Shock
- •12.4. Intravascular administration of iodinated contrast
研究者
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