EUCTR2021-003525-30-DK进行中（未招募）1 期
Effect of colchicine on cardiovascular target organ damage in patients with type 2 diabetes - A randomized placebo-controlled trial
Aarhus University Hospital, Steno Diabetes Center Aarhus0 个研究点目标入组 100 人开始时间: 2021年10月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- All
入选标准
- •- Diagnosis of type 2 diabetes according to the World Health Organization definition
- •- HbA1c level of 6,5 % (48 mmol/mol) or more
- •- High sensitivity C-reactive protein > 2 mg/l
- •- Age of 50 years or more with established cardiovascular disease (prior myocardial infarction, prior stroke or prior transient ischemic attack, prior coronary, carotid or peripheral arterial revascularization, more than 50 % stenosis on angiography or imaging of coronary, carotid or lower extremities arteries, history of symptomatic coronary heart disease documented by e.g. positive exercise stress test or any cardiac imaging or unstable angina with electrocardiography changes
- •Age of 60 years or more with at least one cardiovascular risk factor (persistent microalbuminuria (30-299 mg/g) or proteinuria, hypertension and left ventricular hypertrophy by electrogram or imaging, persistent hypertension despite antihypertensive treatment, left ventricular systolic or diastolic dysfunction by imaging, smoking or ankle/brachial index less than 0.9).
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Previous allergic/hypersensitivity reaction to colchicine
- •- Colchicine treatment for another cause
- •- Poorly controlled medical condition, e.g. congestive heart failure (New York Heart Association III-IV), recent stroke or any other condition that in the opinion of the investigator will put the trial participant at risk if participating in the trial
- •- Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2
- •- Anemia, thrombocytopenia or leucopenia defined as any of the following, measured within the last 3 months:
- •Hemoglobin < 7 mmol/L
- •Platelet count < 110 x 109/L
- •White blood cell count < 3.0 x 109/L
- •- Inability to give informed consent
- •- Active cancer diagnosis other than basal cell carcinoma
- •- Indication of liver disease (serum ALAT above 3 x upper limit of normal)
- •- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- •- Treatment with systemic steroids at time of randomization
- •- Treatment with potent inhibitors of cytochrome P450 3A4 or P-glycoprotein (Appendix 1)
- •- Treatment with any biologic drug targeting the immune system (e.g., TNF-alfa inhibitors)
- •- Vaccination (e.g., against COVID-19) within 14 days prior to inclusion
- •- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- •- Pregnancy or breastfeeding
- •- Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
- •In each group, 15 patients will have FDG-PET/CT performed. These patients cannot have any contraindications to FDG-PET/CT i.e., allergy toward contrast agent.
研究者
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