Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism

Condition(s) studied

Investigational drug(s) / intervention(s)

prospective observational study (clinical, hormonal and auxological data): We collect clinical, hormonal and auxological data and compare them between the two groups.

Study 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.

Eligibility

Primary outcome measure(s)

• Metabolic syndrome (MS) — At the time of enrollment
  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
• Metabolic score (MeTs) — At the time of enrollment
  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

Trial sites (1)

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