Type 2 Diabetes MellitusNCT07847112
Soluble TREM-1 in Diabetes-Associated Cardiovascular Complications
An observational study of Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Diseases, Coronary Artery Disease
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Coronary Artery Disease, Heart Failure, Arrhythmias, Cardiac, Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Ahmed Ali Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847112
- Sponsor's protocol ID
- sTREM-1 and T2DM Heart Disease
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Diabetes-Associated Cardiovascular Complications
- ClinicalTrials.gov ID
- NCT07847112
- Acronym / sponsor ID
- sTREM-1 and T2DM Heart Disease
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUC) of Serum sTREM-1 for Detecting Cardiac Complications
Time frame: Baseline
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (AUC) of Serum sTREM-1 for Detecting Cardiac Complications (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.