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Current methods based on traditional Cardiovascular risk factors are not clinically useful for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in Type 2 Diabetes population have worse prognosis than in general population. In fact, there is sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects of ischemic events and worsens their outcome.
A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes patients. Therefore, new strategies aimed at identifying those patients with this subclinical Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a challenge to be met.
Objectives
1) To examine whether the extension and degree of microangiopathy is an independent risk factor for silent myocardial and brain ischemia. 2) To evaluate whether the degree and extension of microangiopathy is a predictor of CV events and poor outcome. 3) To evaluate whether a new score based on the extension and the degree of microangiopathy will permit us to improve the current methods used to identify patients at risk of CVD and its outcomes. 4) To determine whether the presence and the degree of NAFLD is an independent Cardiovascular disease risk factor and represent and extra-value to the score based on the extension and the degree of microangiopathy.
Secondary objectives:
1) To examine the usefulness of selected serum biomarkers in identifying diabetic patients at risk of Cardiovascular disease 2) To evaluate whether these selected biomarkers are related to the degree and extension of microangiopathy and the outcome of cardiovascular events. 3) To better define the meaning of microalbuminuria in type 2 diabetic population (glomerular involvement vs. index of generalized endothelial dysfunction)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients/Control Group | Observational | ||
| Patients/Group Control | Observational |
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| Measure | Description | Time Frame |
|---|---|---|
| Subclinical Cardiovascular Diseases | Number of Type 2 Diabetes (T2D) patients presenting subclinical Cardiovascular disease as defined by the presence of brain infarcts (MRI), myocardial infarcts, or myocardial ischemia or > 50% coronary artery stenosis (PET-SPECT) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic events |
| 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 200 T2D diabetic patients without history of clinical Cardiovascular disease will be recruited from the Outpatient Diabetic Clinic of Vall d'Hebron Hospital and the Primary Health Care centers under its influence area. Sixty non-diabetic patients without classic Cardiovascular risk factors matched by age will be used as a control group. Specifically, vascular risk factors, concomitant diseases, family history of Cardiovascular disease or stroke and the treatments taken at the time of inclusion will be collected.
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| Name | Affiliation | Role |
|---|---|---|
| David GarcĂa-Dorado Garcia, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Joan Montaner Vilallonga, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Rafael SimĂł Canonge, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Joan SayĂłs Ortega, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Daniel SerĂłn Micas, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Joan GenescĂ Ferrer, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Santiago Aguadé Bruix, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Joan Xavier Comella Carnicé, PhD MD | Hospital Universitario Valle de Hebron, Barcelona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Valle de Hebron | Barcelona | 08035 | Spain |
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Patients: 200 Control group: 60
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003324 | Coronary Artery Disease |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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