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Cardiometabolic Risk of Obese Subjects: Cross-sectional Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06714058
Acronym
MiRNome
Enrollment
240
Registered
2024-12-03
Start date
2024-11-30
Completion date
2025-04-30
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk, Genetics, Obesity and Obesity-related Medical Conditions

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
cycle threshold miRNAsat baselineStudy of the expression profile of specific circulating miRNAs
Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)baselinesearch 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.baselineNGS expression of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.
Insulinemia (µU/mL)baselineLevels of haematic insulin
C-peptide (nmol/L)baselineLevels of haematic of C-peptide
thyrotropin (nmol/L)baselineLevels of haematic of thyrotropin
HMGA1 protein assaybaselineLevels of haematic HMGA1 protein

Countries

Italy

Contacts

Primary ContactMaria Letizia Petroni, MD
marialetizia.petroni@unibo.it+0512143281

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026