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NCT Number: NCT06714058

Cardiometabolic Risk of Obese Subjects: Cross-sectional Study

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.

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Cardiovascular Risk Genetics Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Letizia Petroni, Bologna, BO, Italy

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About this study

Compared to normal clinical practice, if you decide to participate in the study you will be asked to:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. cycle threshold miRNAs

    Time frame: at baseline

    Study of the expression profile of specific circulating miRNAs

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

    Time frame: baseline

    search for variants of the HMGA1 gene

  3. NGS sequencing of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.

    Time frame: baseline

    NGS expression of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.

  4. Insulinemia (µU/mL)

    Time frame: baseline

    Levels of haematic insulin

  5. C-peptide (nmol/L)

    Time frame: baseline

    Levels of haematic of C-peptide

  6. thyrotropin (nmol/L)

    Time frame: baseline

    Levels of haematic of thyrotropin

  7. HMGA1 protein assay

    Time frame: baseline

    Levels of haematic HMGA1 protein

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Letizia Petroni, MD

CONTACT

[email protected]

+0512143281

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: MiRNome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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