Clinical trial
Cardiometabolic Risk of Obese Subjects: Cross-sectional Study
Recruiting now · Not applicable · 1 countries · Registry ID NCT06714058
Recruiting nowNot applicableObservational
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity and Obesity-related Medical Conditions, Cardiovascular Risk, Genetics
Full registry 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.
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
cycle threshold miRNAsat 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 assaybaseline
Levels of haematic HMGA1 protein
Study locations
2 locations were listed when this page was built. The first 40 are shown.
Maria Letizia Petroni🇮🇹 Bologna, BO, Italy
Maria Letizia PetroniContact