Type 2 DiabetesDiabetes-CVNCT06902857
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)
An observational study of Type 2 Diabetes and Cardiovascular Complication, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Complication
- How many people
- 964 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: Subjects with type 2 diabetes attending the outpatient services for the routine checkups.
Who may be able to join
- type 2 diabetes
- patients attending the outpatient services
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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.
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with diabetes | Patients with type 2 diabetes attending routine check-ups at the Diabetology Unit outpatient clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of all-cause mortality
Death from any cause
Measured: From date of enrollment up to 36 months
Secondary outcomes (5)
Change in high-sensitivity cardiac troponin I levels
The levels of high-sensitivity cardiac troponin I will be analyzed.
Measured: At enrollment and 36 months later
The occurence of cardiovascular events
Non-fatal cardiovascular events
Measured: From date of enrollment up to 36 months
The Incidence of new diabetic complications
The onset of new micro and macrovascular complications of diabetes will be recorded
Measured: From date of enrollment up to 36 months
Change in soluble suppression of tumorigenesis-2 levels
The levels of soluble suppression of tumorigenesis-2 will be analyzed.
Measured: From date of enrollment up to 36 months
Change in N-terminal pro-B-natriuretic peptide levels
The levels of N-terminal pro-B-natriuretic peptide will be analyzed.
Measured: From date of enrollment up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start18 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Tortato, MD, Principal investigator, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902857
- Sponsor's protocol ID
- INRCA_002_2025
- Acronym
- Diabetes-CV
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06902857
- Acronym / sponsor ID
- Diabetes-CV / INRCA_002_2025
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 964 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with diabetes | – | –Patients with type 2 diabetes attending routine check-ups at the Diabetology Unit outpatient clinic. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with type 2 diabetes attending the outpatient services for the routine checkups.
Key inclusion criteria (2 listed)
- type 2 diabetes
- patients attending the outpatient services
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurrence of all-cause mortality
Time frame: From date of enrollment up to 36 months
Death from any cause
5 secondary outcomes
Change in high-sensitivity cardiac troponin I levels
Time frame: At enrollment and 36 months later
The occurence of cardiovascular events
Time frame: From date of enrollment up to 36 months
The Incidence of new diabetic complications
Time frame: From date of enrollment up to 36 months
Change in soluble suppression of tumorigenesis-2 levels
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Tortato, MD principal investigator
IRCCS INRCA, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Cardiovascular Complication, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of all-cause mortality (time frame: From date of enrollment up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.