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) (Diabetes-CV)

June 10, 2026 updated by: Istituto Nazionale di Ricovero e Cura per Anziani

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).

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

964

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60127
        • IRCCS INRCA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects with type 2 diabetes attending the outpatient services for the routine checkups.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects with diabetes
Patients with type 2 diabetes attending routine check-ups at the Diabetology Unit outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of all-cause mortality
Time Frame: From date of enrollment up to 36 months
Death from any cause
From date of enrollment up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurence of cardiovascular events
Time Frame: From date of enrollment up to 36 months
Non-fatal cardiovascular events
From date of enrollment up to 36 months
The Incidence of new diabetic complications
Time Frame: From date of enrollment up to 36 months
The onset of new micro and macrovascular complications of diabetes will be recorded
From date of enrollment up to 36 months
Change in high-sensitivity cardiac troponin I levels
Time Frame: At enrollment and 36 months later
The levels of high-sensitivity cardiac troponin I will be analyzed.
At enrollment and 36 months later
Change in soluble suppression of tumorigenesis-2 levels
Time Frame: From date of enrollment up to 36 months
The levels of soluble suppression of tumorigenesis-2 will be analyzed.
From date of enrollment up to 36 months
Change in N-terminal pro-B-natriuretic peptide levels
Time Frame: From date of enrollment up to 36 months
The levels of N-terminal pro-B-natriuretic peptide will be analyzed.
From date of enrollment up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

  • Principal Investigator: Elena Tortato, MD, IRCCS INRCA, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_002_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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