Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Diabetes-Associated Cardiovascular Complications
| Registry | NCT07847112 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 85 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Type 2 Diabetes Mellitus, Cardiovascular Diseases, Coronary Artery Disease, Heart Failure, Arrhythmias, Arrhythmias Cardiac |
| Dates | start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-09-29, last updated 2026-09-29 |
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All trials for Type 2 Diabetes Mellitus All trials for Cardiovascular Diseases
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| T2DM With Cardiac Complications | Adult patients (aged 18-65 years) with established type 2 diabetes mellitus presenting with confirmed cardiac complications (coronary artery disease, heart failure, or arrhythmia) established through structured cardiology assessment, including clinical evaluation, electrocardiogram (ECG), and echocardiography. | ||
| T2DM Without Cardiac Complications | Adult patients (aged 18-65 years) with established type 2 diabetes mellitus confirmed to have no cardiac complications based on structured cardiology assessment, including clinical evaluation, electrocardiogram (ECG), and echocardiography. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * Adult patients aged 18 to 65 years. * Established diagnosis of type 2 diabetes mellitus. * Undergoing structured cardiology assessment (clinical evaluation, electrocardiogram \[ECG\], echocardiography, and further diagnostic testing as indicated) during the study period. * Willingness to provide informed consent. Exclusion Criteria: * Type 1, gestational, or secondary diabetes. * Active infection, sepsis, or acute inflammatory illness at the time of blood sampling. * Known iron-overload states, hemochromatosis, active malignancy, or chronic liver disease.- * Chronic kidney disease requiring dialysis. * Autoimmune or chronic inflammatory disease receiving active treatment. * Pregnancy. * Refusal or inability to provide informed consent.