Clinical trial NCT06714058: Cardiometabolic Risk of Obese Subjects: Cross-sectional Study
Official title: Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity and Obesity-related Medical Conditions
Cardiovascular Risk
Genetics
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: cycle threshold miRNAs
timeFrame: at baseline
measure: Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)
timeFrame: baseline
measure: NGS sequencing of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.
timeFrame: baseline
measure: Insulinemia (µU/mL)
timeFrame: baseline
measure: C-peptide (nmol/L)
timeFrame: baseline
measure: thyrotropin (nmol/L)
timeFrame: baseline
measure: HMGA1 protein assay
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maria Letizia Petroni
state: BO
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria Letizia Petroni, MD
role: PRINCIPAL_INVESTIGATOR
References: