Insulin Resistance SyndromeNCT07785518
Prevalenza Della Insulino Resistenza e Correlate Malattie Cardiovascolari Nella città di Napoli
An observational study of Insulin Resistance Syndrome and Cardio Vascular Disease, run by Comune di Napoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insulin Resistance Syndrome, Cardio Vascular Disease, Prevalence
- How many people
- 123,752 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2026to 30 Jun 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All the subjects registered in the database of COMEGEN aged between 18 and 60 without a diagnosis of diabetes
Who may be able to join
- all the subjects who have a registered value of glucose and triglycerides in the same day within the last 6 months
Who cannot join
- diagnosis of overt diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studio Epidemilogico Per Valutare la Prevalenza Della Insulino Resistenza Nell'Area Metropolitana di Napoli e Della Sua Relazione Con Malattie Cardiovascolari
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.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Insulin Resistance, Cardiovascular disease, Hyperinsulinemia, Prevalence
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Cardiovascular Diseases, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
There is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of insulin resistance
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start25 Jan 2026
- Primary completion6 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Resistance SyndromeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 123,752 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Comune di Napoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785518
- Sponsor's protocol ID
- Protocollo n.29/25 OSS
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Epidemilogico Per Valutare la Prevalenza Della Insulino Resistenza Nell'Area Metropolitana di Napoli e Della Sua Relazione Con Malattie Cardiovascolari
- ClinicalTrials.gov ID
- NCT07785518
- Acronym / sponsor ID
- Protocollo n.29/25 OSS
- Keywords
- Insulin Resistance, Cardiovascular disease, Hyperinsulinemia, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123,752 participants (actual)
- Lead sponsor
- Comune di NapoliUniversity, hospital or other
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 25 Aug 2026 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All the subjects registered in the database of COMEGEN aged between 18 and 60 without a diagnosis of diabetes
Key inclusion criteria (1 listed)
- all the subjects who have a registered value of glucose and triglycerides in the same day within the last 6 months
Key exclusion criteria (1 listed)
- diagnosis of overt diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThere is no intervention | Other | – |
Primary outcome
Prevalence of insulin resistance
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Insulin Resistance Syndrome and Cardio Vascular Disease, run by Comune di Napoli 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of insulin resistance (time frame: 30 days). 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 25 Aug 2026.