Cardiometabolic Risk of Obese Subjects: Cross-sectional Study

NCT06714058 | Recruiting

• 1 other identifier: MiRNome
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• cycle threshold miRNAs

  Study of the expression profile of specific circulating miRNAs

  at baseline

• Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)

  search for variants of the HMGA1 gene

  baseline

• 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.

  baseline

• Insulinemia (µU/mL)

  Levels of haematic insulin

  baseline

• C-peptide (nmol/L)

  Levels of haematic of C-peptide

  baseline

• thyrotropin (nmol/L)

  Levels of haematic of thyrotropin

  baseline

• HMGA1 protein assay

  Levels of haematic HMGA1 protein

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

Maria Letizia Petroni

Bologna, BO, 40138, Italy

RECRUITING

Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro

Catanzaro, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

study-specific blood sampling for the evaluation of the expression profile of circulating miRNAs, the search for variants of the HMGA1 gene and the assay of the HMGA1 protein, of circulating biomarkers of inflammation and insulin resistance.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Letizia Petroni, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Letizia Petroni, MD

CONTACT

+0512143281; marialetizia.petroni@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 3, 2024
• Study Start: November 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-10

Locations

IT (2)