Metabolic SyndromeNCT07181733
BNP in Pediatric Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
MetS is a syndrome characterized by a combination of diabetes, hypertension and visceral obesity, altered blood lipids, beginning in childhood, leading to chronic disease in adulthood. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients whose BNP concentration and echocardiographic parameters was analysed during their first month of life (2009-11) of life at Fondazione IRCCS Policlinico San Matteo
Who may be able to join
- adolescents whose BNP concentration and echocardiographic parameters analysed during their first month of life (2009-11)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
U.O.S. Cardiologia Pediatrica
Pavia, pavia, 27100
Alessia C.A. Codazzi, MD, +390382502915, a.codazzi@smatteo.pv.it
About this study
Official title: Exploring B-Type Natriuretic Peptide (BNP) Evolution, From the Neonatal to Adolescent Period, as a Tool to Early Identify the Risk for Metabolic Syndrome (MetS) in a Former Preterm and Full Term Adolescent Population
MetS is a syndrome characterized by a combination of diabetes, hypertension and visceral obesity, altered blood lipids, beginning in childhood, leading to chronic disease in adulthood. Adult criteria for defining MetS require a minimum of 3 risk factors, listed in the NCEP ATP III (National Cholesterol Education Program, Adult Treatment Panel III, ATP III), they are hyperglycaemia, hypertriglyceridemia, low HDL-C, hypertension, obesity and increased waist circumference.
The pediatric definitions are described mainly by Cooks, Zimmet and de Ferranti are as well based on the presence of ≥ 3 symptoms: obesity (BMI) , waist circumference, glucose intolerance, dyslipidaemia (high triglycerides and/or low HDL-C), High BP. Pediatric criteria of MetS are not univocally defined and symptoms may be fluctuant in adolescent period, therefore the prevalence ranges from 4.2%13 to 9.2%. A number of researchers have used factor analysis of MetS components to develop a risk score to identify children at higher risk for developing MetS. Several MetS risk factors have origins during the prenatal and early postnatal period. In particular, it is known that preterm newborns are more prone to develop this condition once adults, but little is known about the adolescent transition, particularly, in Italy.
Read more
From 2008 - 2011, thirty-four full-term and 36 premature infants were studied, evaluating echocardiographic parameters and BNP concentrations during the first month of life. In this population, now adolescents, it was decided to measure BNP, both current and previous values, in order to verify whether this parameter can be associated with MetS and meet the need to identify high-risk children.
Adolescents affected by MetS were defined on the basis of the available literature: they must present ≥ 3 of the following signs: hyperglycaemia, dyslipidaemia (triglycerides and HDL-C), arterial hypertension, obesity (BMI and waist circumference). Other blood parameters were also evaluated as associated factors, such as white blood cell count, glycosylated haemoglobin, creatinine, urea nitrogen, and suPAR. Doppler echocardiography and tissue Doppler parameters, psychosocial variables (KIDSCREEN-10).
BNP has been shown to play a role not only in heart disease but also in adult patients with obesity, insulin resistance, and diabetes, all of which are present in MetS. Therefore, the primary objective is to assess whether BNP can be an index associated with adolescent MetS. The opportunity was taken to evaluate a population of premature and full-term adolescents. BNP was previously studied in the first month of life, and it is possible to establish a correlation with the adolescent situation. Therefore, the cohort of newborns who are now between 13 and 15 years of age will be recalled.
The data available in the literature and clinical experience suggest a prevalence of metabolic syndrome of between approximately 5 and 10%.
- Conditions
- Metabolic Syndrome
- Keywords
- adolescent, BNP
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects adolescents, born preterm/IUGR | Not described | |
| subjects adolescents, born at term | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of BNP with MetS in adolescent period
we define MetS when an adolescent presents 3 of the following symptoms: hyperglycemia (>110 mg/dl), dyslipidemia (triglycerides <= 120 mg/dl and/or HDL-C < 60 mg/dl), High BP (systolic >120 mmHg diastolic >80 mmHg) , obesity (BMI > 30 and waist circumference > 0.5).
Measured: December 2025
Secondary outcomes (3)
association of BNP in neonatal period and adolescents biomedical measurements
Measured: December 2025
Association of adolescent BNP and MetS within categories of psychosocial variables (as identified by the KIDSCREEN-10 instrument) which are established to have a role in the development of MetS
Psychosocial data:
KIDSCREEN-10 instrument: Self-report questionnaire for the assessment of adolescents' subjective health and health-related quality of life (HRQOL). The normalized score will be then categorized with a cut-off of 50.
Measured: December 2025
Association of BNP in neonatal period with MetS
Measured: December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start8 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessia Claudia Codazzi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181733
- Sponsor's protocol ID
- BNP-MetS
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring B-Type Natriuretic Peptide (BNP) Evolution, From the Neonatal to Adolescent Period, as a Tool to Early Identify the Risk for Metabolic Syndrome (MetS) in a Former Preterm and Full Term Adolescent Population
- ClinicalTrials.gov ID
- NCT07181733
- Acronym / sponsor ID
- BNP-MetS
- Conditions
- Metabolic Syndrome
- Keywords
- adolescent, BNP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Sep 2025 (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.
MetS is a syndrome characterized by a combination of diabetes, hypertension and visceral obesity, altered blood lipids, beginning in childhood, leading to chronic disease in adulthood. Adult criteria for defining MetS require a minimum of 3 risk factors, listed in the NCEP ATP III (National Cholesterol Education Program, Adult Treatment Panel III, ATP III), they are hyperglycaemia, hypertriglyceridemia, low HDL-C, hypertension, obesity and increased waist circumference.
The pediatric definitions are described mainly by Cooks, Zimmet and de Ferranti are as well based on the presence of ≥ 3 symptoms: obesity (BMI) , waist circumference, glucose intolerance, dyslipidaemia (high triglycerides and/or low HDL-C), High BP. Pediatric criteria of MetS are not univocally defined and symptoms may be fluctuant in adolescent period, therefore the prevalence ranges from 4.2%13 to 9.2%. A number of researchers have used factor analysis of MetS components to develop a risk score to identify children at higher risk for developing MetS. Several MetS risk factors have origins during the prenatal and early postnatal period. In particular, it is known that preterm newborns are more prone to develop this condition once adults, but little is known about the adolescent transition, particularly, in Italy.
From 2008 - 2011, thirty-four full-term and 36 premature infants were studied, evaluating echocardiographic parameters and BNP concentrations during the first month of life. In this population, now adolescents, it was decided to measure BNP, both current and previous values, in order to verify whether this parameter can be associated with MetS and meet the need to identify high-risk children.
Adolescents affected by MetS were defined on the basis of the available literature: they must present ≥ 3 of the following signs: hyperglycaemia, dyslipidaemia (triglycerides and HDL-C), arterial hypertension, obesity (BMI and waist circumference). Other blood parameters were also evaluated as associated factors, such as white blood cell count, glycosylated haemoglobin, creatinine, urea nitrogen, and suPAR. Doppler echocardiography and tissue Doppler parameters, psychosocial variables (KIDSCREEN-10).
BNP has been shown to play a role not only in heart disease but also in adult patients with obesity, insulin resistance, and diabetes, all of which are present in MetS. Therefore, the primary objective is to assess whether BNP can be an index associated with adolescent MetS. The opportunity was taken to evaluate a population of premature and full-term adolescents. BNP was previously studied in the first month of life, and it is possible to establish a correlation with the adolescent situation. Therefore, the cohort of newborns who are now between 13 and 15 years of age will be recalled.
The data available in the literature and clinical experience suggest a prevalence of metabolic syndrome of between approximately 5 and 10%.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects adolescents, born preterm/IUGR | – | – |
| subjects adolescents, born at term | – | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients whose BNP concentration and echocardiographic parameters was analysed during their first month of life (2009-11) of life at Fondazione IRCCS Policlinico San Matteo
Key inclusion criteria (1 listed)
- adolescents whose BNP concentration and echocardiographic parameters analysed during their first month of life (2009-11)
Key exclusion criteria (0 listed)
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
Association of BNP with MetS in adolescent period
Time frame: December 2025
we define MetS when an adolescent presents 3 of the following symptoms: hyperglycemia (>110 mg/dl), dyslipidemia (triglycerides <= 120 mg/dl and/or HDL-C < 60 mg/dl), High BP (systolic >120 mmHg diastolic >80 mmHg) , obesity (BMI > 30 and waist circumference > 0.5).
3 secondary outcomes
association of BNP in neonatal period and adolescents biomedical measurements
Time frame: December 2025
Association of adolescent BNP and MetS within categories of psychosocial variables (as identified by the KIDSCREEN-10 instrument) which are established to have a role in the development of MetS
Time frame: December 2025
Association of BNP in neonatal period with MetS
Time frame: December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessia C.A. Codazzi, MD (+390382502915, a.codazzi@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of BNP with MetS in adolescent period (time frame: December 2025). 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 18 Sep 2025.