ISRCTN70518596已完成未知
The effect of the peroxisome proliferator-activated receptor alpha agonist fenofibrate on insulin sensitivity compared to atorvastatin in type 2 diabetes mellitus: A randomised, double-blind controlled trial
Belfast Health and Social Care Trust (UK)0 个研究点目标入组 13 人开始时间: 2008年5月15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
- 13
研究概览
简要总结
- European Association for the Study of Diabetes, 2007 Black RN, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The PPARa agonist fenofibrate does not improve insulin sensitivity in type 2 diabetes in man; results of a randomised trial. Diabetologia 2007; 50(suppl 1): S320. 2. Diabtes UK, 2007 Black RNA, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The effect of PPAR alpha agonist fenofibrate on insulin sensitivity in man: a randomised controlled trial. Diabetic Medicine 2007; 24(suppl 1): 44. 2014 results in https://pubmed.ncbi.nlm.nih.gov/24560135/ (added 12/04/2021)
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males and post-menopausal females
- •2. Aged 35-70 years old
- •3. Type 2 diabetes mellitus, clinically well
- •4. On diet or oral anti-diabetic therapy
- •5. Fasting total triglyceride <4.5 mmol/L
排除标准
- •1. Age <35 or >70 years
- •2. Total fasting triglycerides pre-treatment or after withdrawal of previous therapy >= 4.5mmol/L
- •3. Total cholesterol >6.5 mmol/L
- •4. Excess alcohol consumption
- •5. Ischaemic heart, peripheral vascular or cerebrovascular disease
- •6. Hepatic disease
- •7. Epilepsy
- •8. Body mass index >35 kg/m^2
- •9. Pre-menopausal females
- •10. HbA1c >8%
- •11. Current insulin or thiazolidinedione therapy within 6 months
- •12. Significant renal impairment or overt proteinuria (serum creatinine >150 µmol/L, estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula <50 mL/minute, urine spot albumin >200 mg/L, albumin-creatinine ratio >20 mg/mmol or 24-hour urine protein >300 mg)
- •13. Uncontrolled hypertension (>140/80 mmHg)
研究者
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