Cardiometabolic Risk of Obese Subjects: Cross-sectional Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity and Obesity-related Medical Conditions, Cardiovascular Risk, Genetics. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants
Overview
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.
Primary outcome measures
- cycle threshold miRNAs [Time frame: at baseline]
- Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672) [Time frame: baseline]
- NGS sequencing of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters. [Time frame: baseline]
- Insulinemia (µU/mL) [Time frame: baseline]
- C-peptide (nmol/L) [Time frame: baseline]
- thyrotropin (nmol/L) [Time frame: baseline]
- HMGA1 protein assay [Time frame: baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Maria Letizia Petroni — Bologna
- Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro — Catanzaro
Identifiers
NCT: NCT06714058 · MiRNome