Cardiometabolic Risk of Obese Subjects: Cross-sectional Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
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)
Trial 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)
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
cycle threshold miRNAs
Study of the expression profile of specific circulating miRNAs
Time frame
at baseline2
Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)
search for variants of the HMGA1 gene
Time frame
baseline3
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.
Time frame
baseline4
Insulinemia (µU/mL)
Levels of haematic insulin
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov