- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07847112
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.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
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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. |
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Area Under the Receiver Operating Characteristic Curve (AUC) of Serum sTREM-1 for Detecting Cardiac Complications
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Kärlsjukdomar
- Patologiska processer
- Hjärtsjukdom
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Diabeteskomplikationer
- Kardiomyopatier
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Kranskärlssjukdom
- Myokardischemi
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Hjärtsvikt
- Diabetes mellitus, typ 2
- Hjärt-kärlsjukdomar
- Kranskärlssjukdom
- Arytmier, hjärt
- Diabetiska kardiomyopatier
Andra studie-ID-nummer
- sTREM-1 and T2DM Heart Disease
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