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Clinical Trials/NCT07181733
NCT07181733RecruitingNot Applicable

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

Fondazione IRCCS Policlinico San Matteo di Pavia1 site in 1 country70 target enrollmentStarted: May 8, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Association of BNP with MetS in adolescent period

Study Overview

Brief 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. 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

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
13 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •adolescents whose BNP concentration and echocardiographic parameters analysed during their first month of life (2009-11)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • association of BNP in neonatal period and adolescents biomedical measurements(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(December 2025)
  • Association of BNP in neonatal period with MetS(December 2025)

Investigators

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alessia Claudia Codazzi

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

Study Sites (1)

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