Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-12
SponsorBuzzi Children's Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Pubertal stage Tanner 1
Permanent congenital hypothyroidism
All ethnic groups
Informed consent signature
Disqualifiers
Age< 5 years
Pubertal stage Tanner 2-5
Transient congenital hypothyroidism or other type of hypothyroidism
Trial population
We enrolled patients affected by permanent congenital hypothyroidism in prepubertal age and healthy childrens in prepubertal age to compare them with each other.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
prospective observational study (clinical, hormonal and auxological data)
Other interventionWe collect clinical, hormonal and auxological data and compare them between the two groups.
Treatment groups
170 Participants
are divided into 3 treatment groupsGroup A: Permanent congenital hypothyroidism1 intervention
Group B: Healthy childrens normal weight1 intervention
Group C: Healthy childrens overweight/obese1 intervention
Trial outcomes
Primary outcomes
1
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 enrollment2
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 enrollmentSponsors and contacts
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Buzzi Children's Hospital
Lead sponsor
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
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: