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)

NCT ID: NCT06902857

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1002 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-18

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Cardiovascular Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with diabetes

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Tortato, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS INRCA, Ancona, Italy

Locations

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IRCCS INRCA Hospital

Ancona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anna Rita Bonfigli, PhD

Role: CONTACT

0718003719

Facility Contacts

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Adrianapia Maria Lamedica

Role: primary

0718003854

Other Identifiers

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INRCA_002_2025

Identifier Type: -

Identifier Source: org_study_id

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