Soluble TREM-1 in Diabetes-Associated Cardiovascular Complications

NCT07847112 | Not Yet Recruiting

• 1 other identifier: sTREM-1 and T2DM Heart Disease
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus; Cardiovascular Diseases; Coronary Artery Disease; Heart Failure; Arrhythmias; Arrhythmias Cardiac

Keywords

sTREM-1; Soluble Triggering Receptor Expressed on Myeloid Cells-1; hs-CRP; Ferritin; Diabetic Cardiomyopathy; Cardiovascular Risk Stratification; Endothelial Dysfunction

Outcome Measures

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).

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Coronary Artery Disease; Heart Failure; Arrhythmias, Cardiac; Diabetic Cardiomyopathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Diabetes Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09