Cardiometabolic Risk of Obese Subjects: Cross-sectional Study (MiRNome)

Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Maria Letizia Petroni, MD; Phone Number: +0512143281; Email: marialetizia.petroni@unibo.it

Study Locations

• Italy
  • Catanzaro, Italy
    • Not yet recruiting
    • Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro
    • Contact: Antonio Brunetti, Prof, MD; Email: brunetti@unicz.it
    • Principal Investigator: Antonio Brunetti, Prof, MD
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • Maria Letizia Petroni
      • Contact: Maria Letizia Petroni; Phone Number: +390512143281; Email: marialetizia.petroni@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult patients of both sexes, suffering from grade I obesity, not suffering from atheromatous cardiovascular diseases (ischemic heart disease, ischemic stroke, peripheral arterial disease)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Maria Letizia Petroni, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: MiRNome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No