Clinical trial NCT06902857: Study on the Predictive Value of High-sensitivity Cardiac Troponin I, N-terminal Pro-B-natriuretic Peptide, and Soluble Suppression of Tumorigenesis-2 for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV)
Official title: Prospective Observational Study on the Predictive Value of Cardiac Damage Markers High-sensitivity Cardiac Troponin I (Hs-cTnI), N-terminal Pro-B-natriuretic Peptide (NT-proBNP) and Soluble Suppression of Tumorigenesis-2 (sST2) for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Cardiovascular Complication
Keywords: type 2 diabetes
high-sensitivity cardiac troponin I
N-terminal pro-B-natriuretic peptide
soluble suppression of tumorigenesis-2
mortality risk
diabetes complications
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 1002
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes attending the outpatient services for the routine checkups.

Brief summary: The Diabetes-CV study is an observational study designed to assess the prognostic value of serum cardiac damage markers high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-natriuretic peptide (NT-proBNP), and soluble suppression of tumorigenesis-2 (sST2) in predicting mortality, major adverse cardiovascular events, and diabetic complications in patients with type 2 diabetes.

Detailed description: This single-center, investigator-initiated, prospective observational study aims to evaluate the prognostic value of serum cardiac damage markers such as high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-natriuretic peptide (NT-proBNP) and soluble suppression of tumorigenesis-2 (sST2) in subjects with type 2 diabetes. The study will utilize clinical and laboratory data from patients attending the Diabetology Unit at the IRCCS INRCA Hospital in Ancona (Italy), including both study-specific data and information extracted from routine outpatient medical records.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* patients attending the outpatient services

Exclusion Criteria:

* type 1 diabetes
* patients with active cancer or cancer in remission for less than 5 years
* any medical or other reason that leads the investigator to consider the subject ineligible for the study.

Primary outcomes:
measure: The occurrence of all-cause mortality
timeFrame: From date of enrollment up to 36 months
Secondary outcomes:
measure: Change in high-sensitivity cardiac troponin I levels
timeFrame: At enrollment and 36 months later
measure: The occurence of cardiovascular events
timeFrame: From date of enrollment up to 36 months
measure: The Incidence of new diabetic complications
timeFrame: From date of enrollment up to 36 months
measure: Change in soluble suppression of tumorigenesis-2 levels
timeFrame: From date of enrollment up to 36 months
measure: Change in N-terminal pro-B-natriuretic peptide levels
timeFrame: From date of enrollment up to 36 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Elena Tortato, MD
role: PRINCIPAL_INVESTIGATOR
References: