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Cardiometabolic Risk of Obese Subjects: Cross-sectional Study

NCT ID: NCT06714058

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-04-30

Brief Summary

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experimental study with analysis on tissues. This study aims to study cardiometabolic risk from a genetic, clinical, instrumental and laboratory point of view in a population of subjects with obesity.

Detailed Description

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Compared to normal clinical practice, if you decide to participate in the study you will be asked to:

1. allow the collection of an additional study-specific amount of blood as part of a blood sample already provided for by clinical practice during the dietetic visit; The sample will be used to perform the genetic and laboratory analyses required by the study.
2. Undergo an additional study-specific visit within one month of the dietetic visit. will be subjected to the measurement of the degree of vascular aging and the evaluation of the health of his/her arteries, through non-invasive examinations.

Conditions

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Obesity and Obesity-related Medical Conditions Cardiovascular Risk Genetics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* • Age \> 18 years

* BMI \> 30 Kg/m2
* In primary prevention for cardiovascular disease
* Ability to communicate, make themselves understood and adhere to study-specific procedures
* Willingness to participate in the study and obtain informed consent

Exclusion Criteria

* Patients already enrolled by the Research Units involved in the enrolment
* Glycated hemoglobin level \> 55 mmol/L
* Patients suffering from obesity secondary to endocrinological diseases or iatrogenic causes
* Patients with heterozygous Familial Hypercholesterolemia (Dutch Lipid Score - DLS\>8)
* Patients suffering from hypercholesterolemia secondary to lipid or iatrogenic extra-metabolic pathologies
* Patients suffering from systemic inflammatory or oncological diseases
* Patients on active treatment with GLP-1 analogues
* Pregnancy and breastfeeding
* Any medical or surgical condition that makes the patient's adherence to the study protocol complex or inconsistent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Letizia Petroni, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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Maria Letizia Petroni

Bologna, BO, Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro

Catanzaro, , Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Maria Letizia Petroni, MD

Role: CONTACT

Phone: +0512143281

Email: [email protected]

Facility Contacts

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Maria Letizia Petroni

Role: primary

Antonio Brunetti, Prof, MD

Role: primary

Other Identifiers

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MiRNome

Identifier Type: -

Identifier Source: org_study_id