Plaque Composition in T2DM With and Without Microvascular Complications

NCT06439719 | Not Yet Recruiting

• 1 other identifier: 6561
• Study Type: observational
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Coronary artery calcium score

  Differences in coronary calcium score between subjects with diabetes with and with our microvascular complications

  24 months

Study Arms (2)

T2DM with microvascular complications

T2DM with microvascular complications

Procedure: Blood sample collection

T2DM without microvascular complications

T2DM without microvascular complications

Procedure: Blood sample collection

Interventions

Blood sample collection PROCEDURE

Collection of blood sample

T2DM with microvascular complications; T2DM without microvascular complications

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 * Group B: subjects with T2DM without DMCs

You may qualify if:

• Informed consent signed before any activity related to the study
• Age 40 - 70 years, both sexes
• Diagnosis of T2DM ≥5 years
• CT coronary imaging performed in 60 days before enrollment

You may not qualify if:

• Previous diagnosis of type 1 diabetes, late autoimmune diabetes of the adults (LADA), diabetes secondary to pancreatitis
• Malignant disease
• Acute/chronic inflammatory disease
• Severe obesity

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: May 27, 2024
• Primary Completion: May 27, 2026
• Study Completion: May 27, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05