Characterization of Cardiovascular Risk Profile and Thera... | NCT07375069

Studies
Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy

NCT07375069

Sponsor

Federico II University

Status

Recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

data collection

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 31, 2027Estimated

First Submitted Date

Jan 21, 2026

First Submission Date that Met QC Criteria

Jan 21, 2026

First Posted Date

Jan 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

CardioMET is an observational, multicenter, real-life registry, intending to collect data on patients with Type 2 Diabetes Mellitus, attending internal medicine and cardiology outpatient clinics. The aim of the registry is to characterize the cardiovascular risk profile and pharmacological management of Type 2 Diabetes Mellitus in Italy, in accordance with current ESC and AHA guidelines for primary and secondary prevention of CV disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
data collection	Other	Data collection on diabetes therapy and follow-up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diabetes treatment adherence according to the most recent European Guidelines	Outpatients clinic treatment adherence will be measured as the percentage of patients receiving guideline-directed medical therapy prescriptions.	12-24-36-48 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years;
Diagnosis of type 2 diabetes mellitus (T2DM);
Stable clinical conditions
Outpatient settings
Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

Patients with type 1 diabetes mellitus;
Active participation in interventional studies;
Any condition that may put the patient at risk by participating in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive diabetic patients attending the outpatient clinics, in primary and secondary prevention of cardiovascular disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pasquale Perrone Filardi	Contact	+39081/746224		fpperron@unina.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federico II University of Naples, Department of Advanced Biomedical Sciences	Recruiting	Naples	Napoli	80131	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided