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Life sciences · Observational Study
ClinicalTrials.gov · September 29, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07847112). This is a study registration, not published results. Lead sponsor: Assiut University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 85 participants (ESTIMATED). Conditions: Type 2 Diabetes Mellitus, Cardiovascular Diseases, Coronary Artery Disease, Heart Failure, Arrhythmias, Arrhythmias Cardiac. Primary outcome measures: Area Under the Receiver Operating Characteristic Curve (AUC) of Serum sTREM-1 for Detecting Cardiac Complications , Baseline. Brief summary: Cardiovascular disease is the leading cause of illness and death among individuals with type 2 diabetes mellitus (T2DM). Chronic low-grade inflammation contributes significantly to blood vessel damage, atherosclerosis, and diabetic heart complications. Although conventional inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP) and ferritin are commonly measured, they lack specificity and can be altered by various other health conditions. Soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) is an innate immune receptor biomarker linked to cardiac injury and inflammation, but its diagnostic and predictive value in diabetes-associated cardiovascular complications is not yet well established. The primary purpose of this prospective observational study is to evaluate serum sTREM-1 as an immunoinflammatory biomarker for identifying cardiovascular complications in adults with type 2 diabetes, and to compare its diagnostic performance with hs-CRP and ferritin. Adult participants (aged 18-65 years) with established type 2 diabetes undergoing structured cardiac assessment will have a single venous blood sample drawn alongside their clinical examination, electrocardiogram (ECG), and echocardiogram. Biomarker levels will be compared between participants with confirmed cardiac complications (coronary artery disease, heart failure, or arrhythmias) and those without cardiac complications to determine whether sTREM-1 can improve early cardiovascular risk stratification.