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Checking metabolic health in young children with congenital hypothyroidism

Observes metabolic risk in children aged 5 to 12 with congenital hypothyroidism.

Key facts

Who runs it
Buzzi Children's Hospital
Where
Milan, ItalySee the site
Trial code
Registry title
Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism
Status
Not yet recruiting
People taking part
170 people, planned
Started
Sept 2025
Planned end
Oct 2026
Type of study
Observational, 3 groups
Treatments tested
  • prospective observational study (clinical, hormonal and auxological data)
Record updated
17 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for prepubertal children aged 5 to 12 years with permanent congenital hypothyroidism. It checks their risk of metabolic syndrome.

Age
5 to 12 years
Sex
All sexes
Disease stage
Permanent congenital hypothyroidism. Pubertal stage Tanner 1.

Main reasons for not taking part

  • Younger than 5 years
  • Pubertal stage Tanner 2-5
  • Transient congenital hypothyroidism
  • Other types of hypothyroidism

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 5 and 12 years old?

Where in Italy

  • Buzzi Children's HospitalMilan, ItalyContact: Valeria Calcaterra, Prof, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Permanent congenital hypothyroidism

    170 patients in prepubertal age.

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

  • Healthy childrens normal weight

    170 childrens in prepubertal age.

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

  • Healthy childrens overweight/obese

    170 patients in prepubertal age

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism (IpoMet)
Plain-language title
Checking metabolic health in young children with congenital hypothyroidismGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07126353, who can take part
Record updated
17 August 2025