EUCTR2010-018759-82-FI进行中（未招募）不适用
The Effect of Postprandial Hyperglycemia on Arterial Stiffness in Patients with Type 2 Diabetes
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 89
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
- Male
入选标准
- •Diabetic patients are eligible to be included in the study only if they meet all of the following criteria:
- •[1] Men 45 to 70 years of age.
- •[2] Are diagnosed with T2DM (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
- •[3] Have not smoked in the last 12 hours prior to the study.
- •[4] Have albuminuria but normal kidney function or normal UAER (UAER <20 µg/min or <30 mg/24h, respectively). Patients with or without albuminuria but normal kidney function will be matched for age and BMI.
- •[5] Patients have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
- •[6] Each patient must understand the nature of the study and must sign an ICD.
- •Healthy subjects are eligible to be included in the study only if they meet all of the following criteria:
- •[7] Men 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
- •[8] Normal glucose tolerance (according to the World Health Organization [WHO] criteria, i.e. fasting glucose <6,1 mmol/L and 2-hour glucose <7,8 mmol/L) and normal UAER (UAER between <20 µg/min in the overnight urine collection or <30 mg/24h in the 24 hour urine collection).
- •[9] Healthy subjects have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
- •[10] Each healthy subject must understand the nature of the study and must sign an ICD.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients/healthy subjects will be excluded from the study if they meet any of the following criteria:
- •[11] Have had a cardiovascular event (stroke, myocardial infarction [MI], coronary artery procedure [by-pass surgery or angioplasty], limb amputation due to ischemia, peripheral vascular disease) or coronary heart disease confirmed by exercise test or scintigraphy.
- •[12] Have arrhythmias.
- •[13] Have an acute infection.
- •[14] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •[15] Are Lilly employees.
- •[16] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •[17] Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject.
研究者
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