An observational study in Diabetes Mellitus, Type 2, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Adults with diabetes mellitus have 2-3 times fold increased cardiovascular (CV) risk compared to adults without diabetes, and the risk rises with the worsening of glycaemic control. Adults with type 2 diabetes mellitus (T2DM) and microvascular complications (DMCs) have a higher risk of CV complications than subjects without DMCs. 2023 European Society of Cardiology (ESC) guidelines stated that individuals with T2DM with target organ damage (TOD), defined as presence of microvascular disease in at least three different sites (e.g., microalbuminuria (stage A2) plus retinopathy plus neuropathy), should be considered into a very high CV risk category.
Coronary artery calcium score (CACS) is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging. CACS has become a widely available and accurate tool for determining the risk of major CV events.
The specific role of DMCs in determining the features of coronary plaques is not completely known. A recent study showed how T2DM subjects with obstructive coronary artery disease (CAD) with DMCs at their first coronary event present a more "stable" coronary atherosclerosis features at OCT-imaging, as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs. In this study only subjects with obstructive CAD (defined as a stenosis ≥50% in the left main coronary artery or any stenosis ≥70% or fractional flow reserve \<0.80 in any other major epicardial vessel) were enrolled.
Therefore, further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required.
Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs, focusing on the degree of plaque calcification calculated by the CACS.
Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice.
They will be, therefore, divided into two groups:
Group A: subjects with T2DM with at least one DMC, as defined:
Following data will be collected Anthropometric parameters
Vital signs
Medical history
Medications
Cardiovascular risk scores
Blood Tests data collection
Blood sample collection • CRP
Cardiovascular Autonomic Tests
Following Cardiovascular autonomic tests will be performed:
Neuropathy evaluation
Ophthalmologic evaluation
Coronary CTA parameters collection
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 244 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice.
They will be, therefore, divided into two groups:
Exclusion Criteria:
T2DM with microvascular complications
Procedure: Blood sample collection
T2DM without microvascular complications
Procedure: Blood sample collection
Collection of blood sample
Coronary artery calcium score
Differences in coronary calcium score between subjects with diabetes with and with our microvascular complications
Time frame: 24 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS