NCT07785518

Brief Summary

This is an observational retrospective study to verify the prevalence of insulin resistance (IR) in the municipality of Naples and ita association with cardiovascular diseases. Primary outcome measure 1: The prevalence of IR. Primary outcome measure 2: The prevalence of cardiovascular diseases in subjects with IRnand in subjects without IR. The data for analysis will be derived from the database of COMEGEN, a cooperative of general practitioners (ASL Napoli 1 Centro)who follow about 200,000 individuals of the ten districts of the municipality of Naples. As surrogate index of IR will be used the TyG with the cutoff ≥8.5. Aldo the prevalence of cardiovascular diseases in the two groups will be derivedby the registered cardiovascular diseases in the database.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123,752

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

July 24, 2026

Last Update Submit

August 23, 2026

Conditions

Insulin Resistance SyndromeCardio Vascular DiseasePrevalence

Keywords

Insulin ResistanceCardiovascular diseaseHyperinsulinemiaPrevalence

Outcome Measures

Primary Outcomes (1)

  • Prevalence of insulin resistance

    30 days

Interventions

No Intervention: Observational CohortOTHER

There is no intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All the subjects registered in the database of COMEGEN aged between 18 and 60 without a diagnosis of diabetes

You may qualify if:

  • all the subjects who have a registered value of glucose and triglycerides in the same day within the last 6 months

You may not qualify if:

  • diagnosis of overt diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comune di Napoli

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceCardiovascular DiseasesHyperinsulinism

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

August 25, 2026

Study Start

January 25, 2026

Primary Completion

May 6, 2026

Study Completion

June 30, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)