Aberrant endothelial and smooth muscle progenitor cell frequency and function in Type 2 diabetes: a predisposing factor for increased cardiovascular risk?
- Conditions
- atherosclerosiscardiovascular disease100110821001265310003216
- Registration Number
- NL-OMON35549
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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:
- gender
- age
- smoking
- BMI
- arterial hypertension
- HbA1c (diabetics)
- lipid profile
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method