An observational study in Congenital Hypothyroidism and Metabolic Syndrome, sponsored by Buzzi Children's Hospital. Not yet recruiting at 1 site in Italy. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Buzzi Children's Hospital · Observational
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.
Primary congenital hypothyroidism is the most common endocrine disorder in childhood and can present in either a permanent or transient form. Prolonged thyroid hormone deficiency can cause widespread damage affecting multiple organs and systems. Exposure to thyroid hormone deficiency during fetal and/or neonatal life has particularly severe consequences on the central nervous system, leading to neurocognitive delay. Appropriate and timely hormone replacement therapy (L-thyroxine) can prevent such outcomes, provided it is initiated early.
Thyroid hormones play a crucial role not only in growth and organ development but also in metabolic homeostasis. Thyroid function lies at the crossroads of multiple metabolic pathways. They have multiple effects on glucose and lipid metabolism, specifically by increasing glucose levels, fatty acid oxidation in muscle and liver, and lipolysis in adipose tissue. They also contribute to blood pressure regulation, thereby influencing the prevalence of metabolic syndrome, which is itself a key predictor of type 2 diabetes, cardiovascular diseases, and neurodegenerative conditions.Thyroid function plays a central regulatory role at the intersection of key metabolic pathways. Although, the role of thyroid hormones in metabolic processes is well established, and a bidirectional relationship between metabolic dysfunction and thyroid hypofunction has been reported in the adult population, data on metabolic risk in pediatric patients with congenital hypothyroidism are currently lacking.
The primary aim of this multicenter project is to assess the prevalence of metabolic syndrome in patients with congenital hypothyroidism and to determine whether this population presents a higher metabolic risk profile compared to the general population. As secondary objectives, this prospective study aims to:
Data analysis will be performed using the statistical packages R 4.0.5 (R Core Team, 2021) and STATA (version 15.1, 2017, Stata Corporation, College Station, Texas, USA).
27 studies on the registry are indexed under Congenital Hypothyroidism; 9 are open to participants now.
This study's planned enrollment of 170 is below the median of 241 across 14 observational studies indexed under Congenital Hypothyroidism.
Browse Congenital Hypothyroidism studies →Buzzi Children's Hospital is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We enrolled patients affected by permanent congenital hypothyroidism in prepubertal age and healthy childrens in prepubertal age to compare them with each other.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
170 patients in prepubertal age.
Other: prospective observational study (clinical, hormonal and auxological data)
170 childrens in prepubertal age.
Other: prospective observational study (clinical, hormonal and auxological data)
170 patients in prepubertal age
Other: prospective observational study (clinical, hormonal and auxological data)
We collect clinical, hormonal and auxological data and compare them between the two groups.
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
Time frame: 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
Time frame: At the time of enrollment
Plan to share: Undecided
Start is estimated for Sep 2025; primary completion for Jul 2026, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Buzzi Children's Hospital