FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL) (THYROMETABOL)
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|ClinicalTrials.gov Identifier: NCT02725879|
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : April 15, 2020
|Condition or disease|
Patients with hypothyroidism due to Hashimoto thyroiditis (HT) will receive standard treatment with levothyroxine by their attending physician in order to achieve an euthyroid status. Free T4 level is expected to be displayed within normal range (10-16 mg/dl) after the first few months of levothyroxine administration, and TSH level is expected to be less than 5mU / ml after 3-4 months. Participants will be re-examined in 6 months after the initiation of substitution pharmacotherapy with levothyroxine. Similarly, a control group consisted by healthy children and adolescents matched for age and gender will be re-examined after a 6- month interval from the initial measurements.
From all participants detailed medical history will be recorded and following parameters will be measured and calculated: Age and pubertal stage according Tanner, height, body weight, Body Mass Index (BMI),waist circumference, hip circumference, Mid Arm Circumference (MAC), skinfolds measurement (using a Harpenden skinfold caliper), in order to estimate the percentage (%) body fat. Measurement of RMR, with a portable device applying indirect calorimetry (Fitmate Cosmed, Italy) The blood samples will be collected and centrifuged immediately after the RMR measurement. Following parameters will be tested in serum: FGF-21 (measured by ELISA method), TSH, F-T3, F-T4, TPOAb, TgAb, Fasting Glucose, Insulin, TChol, TG, HDL, LDL, AST, ALT, γGT (applying automatic chemical analyzers and analogues reagents that already exist at the Hospital).
Additionally, a 3-day food dairy (two weekdays and one weekend day) will be completed by the participants and/or their caregivers just a week before the measurement of the RMR and the blood sampling.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Association of Serum Fibroblast Growth Factor 21 (FGF-21) Levels With Resting Metabolic Rate (RMR), in Children and Adolescents With Hashimoto's Thyroiditis.|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
HASIMOTO's PATIENTS (HT)
Children and Adolescents diagnosed with Hashimoto's clinical hypothyroidism.
CONTROL GROUP (C)
Healthy individuals matched for gender and age
- Measurement of FGF-21 serum levels in children and adolescents with Hashimoto's clinical hypothyroidism. [ Time Frame: 1year ]Measurement of FGF-21 serum levels before and after 6 month period with levothyroxine treatment in children and adolescents with Hashimoto's clinical hypothyroidism.
- Measurement of RMR in children and adolescents with Hashimoto's clinical hypothyroidism. [ Time Frame: 1 year ]Measurement of RMR before and after 6 month period with levothyroxine treatment in children and adolescents with Hashimoto's clinical hypothyroidism.
- Comparisons between initial and after 6 months levothyroxine treatment of FGF-21 serum levels and RMR. [ Time Frame: 1 year ]Comparison between the patient's group initial FGF-21 serum levels and RMR before and after levothyroxine treatment. Similar comparison will be done in the control group. Furthermore, a final comparison between patients and controls will be held.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725879
|Contact: Assimina Galli-Tsinopoulou, MD,PhD||2310994801 ext +firstname.lastname@example.org|
|2nd Department of Paediatrics, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA Hospital Thessaloniki, Greece||Recruiting|
|Thessaloniki, Greece, 546 21|
|Contact: Assimina Galli-Tsinopoulou, MD, PhD +302310994801 ext +30 email@example.com|
|Contact: Pavlos Drongitis, RD,MSc 302310994802 ext +30 firstname.lastname@example.org|
|Principal Investigator: Assimina Galli-Tsinopoulou, MD, PhD|
|Sub-Investigator: Pavlos Drongitis, RD,MSc|
|Sub-Investigator: Eleni Papaconstantinou, MD,PhD|
|Sub-Investigator: Dalia Malkova, PhD|
|Principal Investigator:||Assimina Galli-Tsinopoulou, MD,PhD||2nd Department of Paediatrics, AΗEPA Hospital|