TCTR20211110002Enrolling By Invitation4 期
Effect of low-dose colchicine on arterial stiffness assessed by cardio-ankle vascular index in patients with diabetes mellitus
Faculty of Medicine, Prince of Songkhla University0 个研究点目标入组 60 人开始时间: 2021年11月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 40 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Type 2 diabetes melitus
- •2. Met one of the following conditions: hyperlipidemia, hypertension, obesity defined as BMI greater than 25 kg/m2 or a waist circumference greater than 90 cm in males, or 80 cm in females
排除标准
- •1. Diabetic patients using insulin or had significant proteinuria
- •2. History of heart failure, or documented left ventricular ejection fraction less than 50%
- •3. Coronary artery diseases
- •4. History of myocardial infarction, ischemic stroke, peripheral arterial disease
- •5. Recent smoking within 1 year prior to enrollment
- •6. Hypertensive or diabetic medications were recent adjusted in previous 3 months prior to enrollment
- •7. Atrial fibrillation
- •8. Pateints with untreated, being treated malignancy, or evidence of tumor recurrence within 5 years
- •9. History of inflammatory bowel disease
- •10. Patients with chronic diarrhea
- •11. History of neuromuscular disease
- •12. Patients with cirrhosis or chronic hepatitis viral infection or severe liver dysfunction
- •13. Elevated liver enzyme greater than 3 times of upper reference value
- •14. Creainine clearance less than 50 ml/min
- •15. Hemoglobin level less than 10 g/dL, or white blood cells less than 3,000 /mm3, or platelets less than 110,000 /mm3
- •16. Patients with HIV infection
- •17. History of colchicine use in previous 1 month before enrollment
- •18. Patients with suspected fungal infection or being treated with angifungal drugs
- •19. Female with planned or being pregnancy or breastfeeding within 1 year
- •20. History of colchicine allergy
- •21. Patients with ongoing or planned treatment with steroids
- •22. Concurrent medications affecting to colchicine e.g. macrolides, antifungal medication (azole group, griseofulvin), verapamil, diltiazem, high dose simvastatin and atorvastatin
- •23. Patients taking strong CYP3A4 inhibitors
- •24. Elevated creatinine phosphokinase greater than 3 times of upper reference value
- •25. Patients is participating other research program
研究者
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