Understanding cardiometabolic risks in obese individuals
Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06714058
This study looks at the health risks related to obesity by testing blood samples and checking blood vessel health in people who are obese.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 2 sites (Bologna, BO and 1 other locations) |
| Trial ID | NCT06714058 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze cardiometabolic risk factors in obese individuals from genetic, clinical, instrumental, and laboratory perspectives. Participants will provide additional blood samples during routine dietetic visits for genetic and laboratory analyses. They will also undergo non-invasive examinations to assess vascular aging and arterial health within a month of their dietetic visit. The study seeks to deepen the understanding of obesity-related health risks and their underlying mechanisms.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a BMI greater than 30 who are in primary prevention for cardiovascular disease.
Not a fit: Patients with obesity due to endocrinological diseases, systemic inflammatory or oncological conditions, or those on specific treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing obesity and its associated cardiovascular risks.
How similar studies have performed: Other studies have shown success in understanding cardiometabolic risks in obese populations, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna, BO and 1 other locations
- Maria Letizia Petroni — Bologna, BO, Italy (RECRUITING)
- Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro — Catanzaro, Italy (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Maria Letizia Petroni, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Maria Letizia Petroni, MD
- Email: marialetizia.petroni@unibo.it
- Phone: +0512143281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity and Obesity-related Medical Conditions, Cardiovascular Risk, Genetics