Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism

NCT07126353 | Not Yet Recruiting

• 1 other identifier: CET 503-2024
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

We propose a multicenter prospective study to define the prevalence and severity score of metabolic syndrome in a prepubertal pediatric cohort with congenital hypothyroidism, compared to a healthy and normal-weight pediatric population. These data will help to define whether hypothyroidism can be considered a risk factor for the metabolic health of the pediatric population. The possible identification of an at-risk metabolic profile will provide useful information to optimize the diagnostic and monitoring pathway for affected children.

Conditions

Congenital Hypothyroidism; Metabolic Syndrome

Keywords

Congenital hypothyroidism; metabolic syndrome; Obesity

Outcome Measures

Primary Outcomes (2)

• Metabolic syndrome (MS)

  Presence of at least 3 of the following parameters: 1. BMI z-score ≥ 2 and/or waist-to-height ratio (WHtR) \> 0.5 2. Fasting blood glucose ≥ 100 mg/dL and/or TryG index ≥ 7.88 3. Total cholesterol ≥ 200 mg/dL 4. HDL cholesterol \< 40 mg/dL and/or LDL cholesterol ≥ 130 mg/dL 5. Triglycerides (TG) ≥ 100 mg/dL for ages 0-9 years; ≥ 130 mg/dL for ages \>10 years 6. Systolic and/or diastolic blood pressure (SBP and/or DBP) ≥ 90th percentile for age and sex

  At the time of enrollment

• Metabolic score (MeTs)

  Males MetS z-score = -4.931 + 0.2804 \* BMI z-score - 0.0257 \* HDL + 0.0189 \* SBP + 0.6240 \* log(triglycerides) + 0.0140 \* fasting glucose Females MetS z-score = -4.3757 + 0.4849 \* BMI z-score - 0.0176 \* HDL-C + 0.0257 \* SBP + 0.3172 \* log(triglycerides) + 0.0083 \* fasting glucose

  At the time of enrollment

Study Arms (3)

Permanent congenital hypothyroidism

170 patients in prepubertal age.

Other: prospective observational study (clinical, hormonal and auxological data)

Healthy childrens normal weight

170 childrens in prepubertal age.

Other: prospective observational study (clinical, hormonal and auxological data)

Healthy childrens overweight/obese

170 patients in prepubertal age

Other: prospective observational study (clinical, hormonal and auxological data)

Interventions

prospective observational study (clinical, hormonal and auxological data) OTHER

We collect clinical, hormonal and auxological data and compare them between the two groups.

Healthy childrens normal weight; Healthy childrens overweight/obese; Permanent congenital hypothyroidism

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We enrolled patients affected by permanent congenital hypothyroidism in prepubertal age and healthy childrens in prepubertal age to compare them with each other.

You may qualify if:

• Pubertal stage Tanner 1
• Permanent congenital hypothyroidism
• All ethnic groups
• Informed consent signature

You may not qualify if:

• Age\< 5 years
• Pubertal stage Tanner 2-5
• Transient congenital hypothyroidism or other type of hypothyroidism

Sponsors & Collaborators

• Buzzi Children's Hospital: lead
• Federico II University: collaborator
• IRCCS Ospedale San Raffaele: collaborator
• Policlinico di Bari Giovanni XXIII: collaborator
• Azienda Ospedaliero Universitaria Policlinico Modena: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna: collaborator
• Azienda Ospedaliera Sant'Anna: collaborator
• University Hospital Perugia: collaborator
• University of L'Aquila: collaborator
• Clinica Pediatrica Università di Novara: collaborator
• Santobono-Pausilpon Hospital: collaborator
• Policlinico G . Martino, Messina Italy: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• University Hospital of Ancona: collaborator

Study Sites (1)

Buzzi Children's Hospital

Milan, 20154, Italy

Location

Related Publications (17)

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• Lakhani G, Patel P, Patel TC. A Cross-Sectional Study on the Prevalence of Subclinical Hypothyroidism in Metabolic Syndrome Patients at a Tertiary Care Hospital. Cureus. 2024 Aug 26;16(8):e67851. doi: 10.7759/cureus.67851. eCollection 2024 Aug.

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  PMID: 38982986 BACKGROUND

• Di Bonito P, Corica D, Marzuillo P, Di Sessa A, Licenziati MR, Faienza MF, Calcaterra V, Franco F, Maltoni G, Valerio G, Wasniewska M. Sensitivity to Thyroid Hormones and Reduced Glomerular Filtration in Children and Adolescents with Overweight or Obesity. Horm Res Paediatr. 2024;97(4):383-387. doi: 10.1159/000534472. Epub 2023 Oct 9.

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• Calcaterra V, Mameli C, Macedoni M, De Silvestri A, Sgambetterra L, Nosenzo F, Redaelli FC, Petitti A, Bosetti A, Zuccotti G. Investigating the connection among thyroid function, sensitivity to thyroid hormones, and metabolic syndrome in euthyroid children and adolescents affected by type 1 diabetes. J Pediatr Endocrinol Metab. 2024 Mar 12;37(4):347-352. doi: 10.1515/jpem-2023-0565. Print 2024 Apr 25.

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• Calcaterra V, Gazzarri A, De Silvestri A, Madia C, Baldassarre P, Rossi V, Garella V, Zuccotti G. Thyroid function, sensitivity to thyroid hormones, and metabolic syndrome in euthyroid children and adolescents with Down syndrome. J Endocrinol Invest. 2023 Nov;46(11):2319-2325. doi: 10.1007/s40618-023-02086-4. Epub 2023 Apr 11.

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MeSH Terms

Conditions

Congenital Hypothyroidism; Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hypothyroidism; Thyroid Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Valeria Calcaterra, MD

CONTACT

+39 0263631; valeria.calcaterra@unipv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

IT (1)