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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Alessia C.A. Codazzi, MD contact

+390382502915

a.codazzi@smatteo.pv.it

Italy1 site, 1 recruiting
  • U.O.S. Cardiologia Pediatrica

    Pavia, pavia, 27100

    Alessia C.A. Codazzi, MD, +390382502915, a.codazzi@smatteo.pv.it

    Recruiting

Other trials in Italy

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%.

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 groups in NCT07181733
Study groupRoleWhat they receive
subjects adolescents, born preterm/IUGRNot described
subjects adolescents, born at termNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. association of BNP in neonatal period and adolescents biomedical measurements

    Measured: December 2025

  2. 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

  3. 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.

  1. First posted18 Sep 2025
  2. Study start8 May 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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

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.

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