Cardiometabolic Risk of Obese Subjects: Cross-sectional Study

Recruiting

• Conditions: Obesity and Obesity-related Medical Conditions; Cardiovascular Risk; Genetics

• Registration Number: NCT06714058
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-11-28
• Study Start: 2024-11-30
• Study First Posted: 2024-12-03
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cycle threshold miRNAs	at baseline	Study of the expression profile of specific circulating miRNAs
Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)	baseline	search for variants of the HMGA1 gene
NGS sequencing of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.	baseline	NGS expression of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.
Insulinemia (µU/mL)	baseline	Levels of haematic insulin
C-peptide (nmol/L)	baseline	Levels of haematic of C-peptide
thyrotropin (nmol/L)	baseline	Levels of haematic of thyrotropin
HMGA1 protein assay	baseline	Levels of haematic HMGA1 protein

Trial Locations

Locations (2)

Maria Letizia Petroni; 🇮🇹 Bologna, BO, Italy

Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro; 🇮🇹 Catanzaro, Italy