Soluble TREM-1 in Diabetes-Associated Cardiovascular Complications
Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Diabetes-Associated Cardiovascular Complications
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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
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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. |
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Area Under the Receiver Operating Characteristic Curve (AUC) of Serum sTREM-1 for Detecting Cardiac Complications
Délai: Baseline
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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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies vasculaires
- Processus pathologiques
- Maladies cardiaques
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Diabète sucré
- Complications du diabète
- Cardiomyopathies
- Artériosclérose
- Maladies artérielles occlusives
- Maladie coronarienne
- Ischémie myocardique
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Insuffisance cardiaque
- Diabète sucré, Type 2
- Maladies cardiovasculaires
- Maladie de l'artère coronaire
- Arythmies cardiaques
- Cardiomyopathies diabétiques
Autres numéros d'identification d'étude
- sTREM-1 and T2DM Heart Disease
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