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)

NCT06902857 | Recruiting

• 1 other identifier: INRCA_002_2025
• Study Type: observational
• Target: 1,002
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The occurrence of all-cause mortality

  Death from any cause

  From date of enrollment up to 36 months

Secondary Outcomes (5)

• Change in high-sensitivity cardiac troponin I levels

  At enrollment and 36 months later

• The occurence of cardiovascular events

  From date of enrollment up to 36 months

• The Incidence of new diabetic complications

  From date of enrollment up to 36 months

• Change in soluble suppression of tumorigenesis-2 levels

  From date of enrollment up to 36 months

• Change in N-terminal pro-B-natriuretic peptide levels

  From date of enrollment up to 36 months

Study Arms (1)

Subjects with diabetes

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• type 2 diabetes
• patients attending the outpatient services

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Study Sites (1)

IRCCS INRCA Hospital

Ancona, 60127, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples will be stored at -80°C at the BioGer biobank of IRCCS INRCA.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elena Tortato, MD

  IRCCS INRCA, Ancona, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rita Bonfigli, PhD

CONTACT

0718003719; a.bonfigli@inrca.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: April 18, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)