NL-OMON35549已完成不适用
Aberrant endothelial and smooth muscle progenitor cell frequency and function in Type 2 diabetes: a predisposing factor for increased cardiovascular risk? - Vascular progenitor cells in Type 2 diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients eligible for participation are diagnosed with T2DM (duration 10-15 yrs) and divided into diabetic patients with PAD, with CAD or without cardiovascular disease. Patients eligible for participation in the various control groups are patients without a history of T2DM but with PAD or CAD, respectively. In addition, healthy individuals who have neither a history of diabetes, cardiovascular disease, inflammatory or autoimmune disease, nor obesity nor any other chronic disease are will be included.;Definitions PAD and CAD:;Peripheral artery disease (PAD)
- •PAD is defined by the presence of carotid stenosis or lower extremity atherosclerosis obliterans. Severity of atherosclerosis of carotid vessels will be assessed by ultrasonography as a continuous variable. Diagnosis of atherosclerotic involvement of the lower extremities will be assessed by history of claudication or rest pain, bilateral pulses examination (dorsal pedal, posterior tibial, popliteal, and femoral arteries), ultrasonography performed bilaterally at levels of popliteal and femoral arteries, and, eventually, angiography. Patients are then classified according to the Leriche/Fontaine clinical classification of lower limb atherosclerosis obliterans.;Coronary artery disease (CAD)
- •CAD is defined as previous myocardial infarction, resting ECG indicative of past MI, positive ECG at exercise stress test, echocardiography stress-test positive for inducible ischemia, evidence of significant coronary artery stenose on angiography with or without typical chest pain. ;Participants allocated to the different groups will be matched for:
- •- arterial hypertension
- •- HbA1c (diabetics)
- •- lipid profile
排除标准
- •Predefined exclusion criteria for T2DM include diagnosis of T1DM and presence of any of the following (self-reported) medical conditions:
- •- microvascular disease (diabetic retinopathy and nephropathy)
- •- auto-immune diseases
- •- current or prior cancers
- •- acute or chonic infection
- •- recent surgery or vascular intervention
- •- age >80yrs
- •- recent myocardial infarction
- •- hemodialysis
- •- immunosuppression
- •- any other unrelated disease;Exclusion criteria for non-diabetics include:
- •- diagnosis of T1DM or T2DM
- •- auto-immune diseases
- •- current or prior cancers
- •- acute or chonic infection
- •- recent surgery or vascular intervention
- •- age >80yrs
- •- recent myocardial infarction
- •- hemodialysis
- •- immunosuppression
- •- any other unrelated disease
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