Type 2 Diabetes Mellitus and Atherosclerosis

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In individuals with Type 2 Diabetes (T2D) it has been obtained an outstanding improvement in the management of hyperglycemia, but it has not been achieved a similar result in the reduction of the atherosclerotic syndrome. The comprehension of the mechanisms that link over nutrition to inflammation and innate immune response can be important to understand the relationship between insulin resistance, diabetes mellitus and endothelial dysfunction. It will be investigated: 1) the role of Toll Like Receptors (TLR)s in the pathophysiology of T2D and associated atherosclerosis; 2) the role of aspirin and nicotinamide adenine dinucleotide phosphate (NADPH) oxidase inhibitor/s in the production of TxA2 and F2-isoprostanes in T2D patients; 3)new biomarkers associated to Diabetes and atherosclerosis including markers of endothelial dysfunction and cytokines.

It will be analyzed in isolated platelets from normal controls and/or diabetic patients the production of TxA2, isoprostanes and pro-inflammatory/thrombotic cytokines using aspirin and NADPHoxidase inhibitors.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Collaborator: University of Rome Tor Vergata
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus (defined according to the criteria of the American Diabetes Association)

• Sign of a written informed consent to participate to the interventional study

Exclusion Criteria:

• Liver disease

• Serious renal disorders (serum creatinine >2.5 mg/dL)

• History or evidence of previous major vascular events (myocardial infarction, transient ischemic attack, stroke)

• History of major bleeding

• Autoimmune diseases

• Cancer or present or recent infections

• Use of non-steroidal anti-inflammatory drugs, drugs interfering with cholesterol metabolism, or vitamin supplements or antiplatelet drugs in the previous 30 days