Clinical Trial: FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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.

Brief Summary: Thyroid hormone (TH) and fibroblast growth factor 21 (FGF-21) are reported to share common metabolic pathways and underlying mechanisms in terms of energy balance, thus affecting both thermogenesis and resting metabolic rate (RMR). Although FGF-21 levels has been studied in children and adolescents regarding obesity, body composition and insulin resistance, data in children and adolescents diagnosed with Hashimoto's thyroiditis are lacking. Therefore, the purpose of this study is to measure the RMR in children and adolescents diagnosed with clinical hypothyroidism due to thyroiditis Hashimoto just before starting levothyroxine treatment and after six months achieving an euthyroid state, and to detect any association between serum FGF-21 levels and RMR.

Detailed Summary:

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.


Sponsor: Aristotle University Of Thessaloniki

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Aristotle University Of Thessaloniki

Dates:
Date Received: January 9, 2016
Date Started: March 2016
Date Completion: January 2019
Last Updated: March 29, 2016
Last Verified: March 2016