Obesity and Obesity-related Medical ConditionsMiRNomeNCT06714058
Cardiometabolic Risk of Obese Subjects: Cross-sectional Study
An observational study of Obesity and Obesity-related Medical Conditions and Cardiovascular Risk, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Cardiovascular Risk, Genetics
- How many people
- 240 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Nov 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- • 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Maria Letizia Petroni
Bologna, BO, 40138
Maria Letizia Petroni, +390512143281, marialetizia.petroni@unibo.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro
Catanzaro
Antonio Brunetti, Prof, MD, brunetti@unicz.it
Antonio Brunetti, Prof, MD
About this study
Official title: Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants
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.
Read the detailed description
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.
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
cycle threshold miRNAs
Study of the expression profile of specific circulating miRNAs
Measured: at baseline
Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)
search for variants of the HMGA1 gene
Measured: 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.
Measured: baseline
Insulinemia (µU/mL)
Levels of haematic insulin
Measured: baseline
C-peptide (nmol/L)
Levels of haematic of C-peptide
Measured: baseline
thyrotropin (nmol/L)
Levels of haematic of thyrotropin
Measured: baseline
HMGA1 protein assay
Levels of haematic HMGA1 protein
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Letizia Petroni, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714058
- Sponsor's protocol ID
- MiRNome
- Acronym
- MiRNome
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants
- ClinicalTrials.gov ID
- NCT06714058
- Acronym / sponsor ID
- MiRNome / MiRNome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- • Age > 18 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cycle threshold miRNAs
Time frame: at baseline
Study of the expression profile of specific circulating miRNAs
Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)
Time frame: baseline
search 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.
Time frame: baseline
NGS expression of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.
Insulinemia (µU/mL)
Time frame: baseline
Levels of haematic insulin
C-peptide (nmol/L)
Time frame: baseline
Levels of haematic of C-peptide
thyrotropin (nmol/L)
Time frame: baseline
Levels of haematic of thyrotropin
HMGA1 protein assay
Time frame: baseline
Levels of haematic HMGA1 protein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Related trials for Obesity and Obesity-related Medical Conditions
Recruiting
Transition to Ambulatory Bariatric Surgery (TABS) Trial
Obesity and Obesity-related Medical Conditions, Bariatric Surgery
Active, not recruitingEarly Phase 1
Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Obesity and Obesity-related Medical Conditions
Recruiting
A Wearable Device and AI-Supported Diet and Exercise Intervention
Obesity and Obesity-related Medical Conditions
Recruiting
Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)
Appetite, Obesity and Obesity-related Medical Conditions
Active, not recruitingPhase 4
Bariatric Surgery vs. Semaglutide vs. Tirzepatide
Obesity and Obesity-related Medical Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Letizia Petroni, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity-related Medical Conditions and Cardiovascular Risk, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Letizia Petroni, MD (+0512143281, marialetizia.petroni@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cycle threshold miRNAs (time frame: at baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.