Soluble TREM-1 in Diabetes-Associated Cardiovascular Complications

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult patients aged 18 to 65 years with an established diagnosis of type 2 diabetes mellitus who are undergoing structured cardiology assessment (including clinical examination, electrocardiogram, and echocardiography) at Assiut University Hospitals (Departments of Internal Medicine and Clinical Pathology), Assiut, Egypt.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

85 Participants
are grouped into 2 trial groups
Group A: T2DM With Cardiac Complications
Group B: T2DM Without Cardiac Complications

Trial outcomes

Primary outcomes

1

Area Under the Receiver Operating Characteristic Curve (AUC) of Serum sTREM-1 for Detecting Cardiac Complications

The Area Under the Receiver Operating Characteristic Curve (AUC) will be calculated to assess the overall diagnostic accuracy of serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1, measured by ELISA) in distinguishing type 2 diabetes mellitus patients with confirmed cardiac complications (coronary artery disease, heart failure, or arrhythmia) from those without cardiac complications. The AUC metric ranges from 0.5 (no discriminative ability) to 1.0 (perfect diagnostic accuracy).

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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