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NCT Number: 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)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Cardiovascular Complication Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS INRCA Hospital

Ancona, 60127, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The occurrence of all-cause mortality

    Time frame: From date of enrollment up to 36 months

    Death from any cause

Secondary outcomes

  1. 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.

  2. The occurence of cardiovascular events

    Time frame: From date of enrollment up to 36 months

    Non-fatal cardiovascular events

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Registry information

Official study 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).

Acronym: Diabetes-CV

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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