FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL)
NCT ID: NCT02725879
Last Updated: 2024-02-20
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Total Enrollment
90 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-10-31
Study Completion Date
2020-03-31
Brief Summary
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It is well documented that thyroid hormones (THs) are involved in energy and lipid metabolism, thermogenesis, and body weight control, acting on several tissues. Thus, any change in thyroid status may affect body weight and metabolic rate. On the other hand, fibroblast growth factor 21 (FGF-21) is a complex hormone involved in energy, lipid, and glucose metabolism, sharing common biochemical pathways and sites of action with THs. FGF-21 is synthesized and acts primarily on the liver, but weaker expression has also been described in muscle, pancreas, and adipose tissue. In addition, FGF-21 acts through endocrine and paracrine mechanisms, regulating metabolic pathways such as fatty acid oxidation, glucose uptake, and thermogenesis. Recent animal and human studies have highlighted a close bidirectional relationship between FGF-21 and THs, partially elucidated. Thyroid hormones regulate the expression of the FGF-21 gene in the liver and can also increase FGF-21 levels in vivo. However, it has also been suggested that some of their key actions are largely independent. Data on FGF-21 levels and their metabolic role in pediatric patients with chronic autoimmune thyroiditis (AIT) are scarce. This study aims to measure FGF-21 serum levels in children and adolescents with Hashimoto's thyroiditis and investigate any possible associations between FGF-21 serum levels and resting metabolic rate (RMR) and levothyroxine (LT4) treatment, or other clinical and biochemical parameters.
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Detailed Description
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Children and adolescents, aged 5-18 years, will undergo routine screening for chronic autoimmune thyroiditis (AIT) at the Pediatric Endocrinology Outpatient Clinic of "Papageorgiou" General Hospital and "AHEPA" University Hospital of Thessaloniki, Greece. The diagnosis of AIT will be based on the presence of anti-thyroid autoantibodies (Anti-TPOAb and/or Anti-TgAb) and one or more of the following: clinical symptoms of thyroid dysfunction, goiter, or diffuse/irregular hypoechogenicity of the thyroid gland during an ultrasound examination.
All participants should have a normal body mass index (BMI) for their age and sex, be drug-naive for at least 3 months, follow no special diet, and have no chronic and/or acute disease or menstrual disorder. Only those subjects that will start routine LT4 treatment will be reassessed at six months (not the rest participants), with no specific intervention to take place during those six months.
For all participants, a detailed medical history will be recorded. The following parameters will be measured and calculated: age and pubertal stage according to Tanner, height, body weight, Body Mass Index (BMI), waist circumference, hip circumference, mid-upper arm circumference (MUAC), and skinfolds measurement in order to estimate the percentage of body fat (%BF). The resting metabolic rate (RMR) will be measured with a portable device applying indirect calorimetry. Blood samples will be collected after overnight fasting.
The following parameters will be tested in serum: thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), anti-thyroid peroxidase antibody (Anti-TPOAb) titers, thyroglobulin antibody (Anti-TgAb) titers, total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), aspartate aminotransferase (AST), alanine aminotransferase (ALT), γglutamyltransferase (γ-GT), alkaline phosphatase (ALP), applying an automatic chemical analyzer or immunoassay system and analogs reagents that already exist at the hospital. Serum FGF-21 levels will be determined in pg/mL using the Solid Phase Sandwich Enzyme-linked Immunosorbent Assay (ELISA) method according to the manufacturer's protocol.
Additionally, all participants, with the help of their parents and/or caregivers, will complete the Mediterranean Diet Index (KIDMED) at their first visit.
All participants should have a normal body mass index (BMI) for their age and sex, be drug-naive for at least 3 months, follow no special diet, and have no chronic and/or acute disease or menstrual disorder. Only those subjects that will start routine LT4 treatment will be reassessed at six months (not the rest participants), with no specific intervention to take place during those six months.
For all participants, a detailed medical history will be recorded. The following parameters will be measured and calculated: age and pubertal stage according to Tanner, height, body weight, Body Mass Index (BMI), waist circumference, hip circumference, mid-upper arm circumference (MUAC), and skinfolds measurement in order to estimate the percentage of body fat (%BF). The resting metabolic rate (RMR) will be measured with a portable device applying indirect calorimetry. Blood samples will be collected after overnight fasting.
The following parameters will be tested in serum: thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), anti-thyroid peroxidase antibody (Anti-TPOAb) titers, thyroglobulin antibody (Anti-TgAb) titers, total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), aspartate aminotransferase (AST), alanine aminotransferase (ALT), γglutamyltransferase (γ-GT), alkaline phosphatase (ALP), applying an automatic chemical analyzer or immunoassay system and analogs reagents that already exist at the hospital. Serum FGF-21 levels will be determined in pg/mL using the Solid Phase Sandwich Enzyme-linked Immunosorbent Assay (ELISA) method according to the manufacturer's protocol.
Additionally, all participants, with the help of their parents and/or caregivers, will complete the Mediterranean Diet Index (KIDMED) at their first visit.
Conditions
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Hashimoto Disease
Study Design
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Observational Model Type
OTHER
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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AIT Subclinical Hypothyroid Group
30 children and adolescents with subclinical hypothyroidism due to Hashimoto's thyroiditis.
No special intervention is to be administered, only routine LT4 treatment. Reassessment at 6 months.
No interventions assigned to this group
Control Group
30 healthy individuals with no chronic autoimmune thyroiditis and normal thyroid function (age- and sex-matched with the AIT Subclinical Hypothyroid Group).
No special intervention is to be administered. No reassessment at 6 months.
No interventions assigned to this group
AIT Euthyroid Group
30 children and adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with the AIT Subclinical Hypothyroid Group).
No special intervention is to be administered. No reassessment at 6 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
For patients
* Subjects 5 to 18 years old.
* First diagnosis of chronic autoimmune thyroiditis (high levels of serum antithyroid autoantibodies anti-TPO, anti-TgAb).
For Controls:
* Healthy individuals 5 to 18 years old.
* BMI for age between 15th and 85th percentile (z-score between -1 and +1).
* Subjects 5 to 18 years old.
* First diagnosis of chronic autoimmune thyroiditis (high levels of serum antithyroid autoantibodies anti-TPO, anti-TgAb).
For Controls:
* Healthy individuals 5 to 18 years old.
* BMI for age between 15th and 85th percentile (z-score between -1 and +1).
Exclusion Criteria
For patients
* Pre-existing medical treatment for thyroid disease
* Taking other medications (eg growth hormone, corticosteroids) in the last 3 months.
* Taking food supplements (eg omega-3 fatty acids, amino acids) in the last 3 months.
* Concomitant endocrine, metabolic, degenerative, and/or chronic diseases other than obesity (eg diabetes, hyper/ hypercortisolemia, cardiovascular diseases, kidney diseases, myasthenia, neurological diseases, psychiatric disorders eg anorexia nervosa, cancer, anemia, celiac disease, chromosomal abnormalities eg syndrome Turner, Down, etc).
* Participation in any daily organized physical activity (sport), more than 1 hour per day.
* Presence of menstrual disorders in adolescent girls.
* Having any kind of nutrition/dietary intervention (eg weight loss diet, hypocaloric, ketogenic, low-protein diet), in the last 6 months.
For Controls:
* Presence of any form of thyroid disease.
* Presence of any endocrine, metabolic, degenerative, and/or chronic disease (eg diabetes, hyper/ hypercortisolemia, obesity, metabolic syndrome, cardiovascular diseases, kidney diseases, myasthenia, neurological diseases, psychiatric disorders eg anorexia nervosa, cancer, anemia, celiac disease, chromosomal abnormalities eg syndrome Turner, Down, etc).
* Taking any medication (eg growth hormone, corticosteroids) in the last 3 months.
* Taking food supplements (eg omega-3 fatty acids, amino acids) in the last 3 months.
* Participation in any daily organized physical activity (sport), more than 1 hour per day. Presence of menstrual disorders in adolescent girls.
* Having any kind of nutrition/dietary intervention (eg weight loss diet, hypocaloric, ketogenic, low-protein diet), in the last 6 months.
* Pre-existing medical treatment for thyroid disease
* Taking other medications (eg growth hormone, corticosteroids) in the last 3 months.
* Taking food supplements (eg omega-3 fatty acids, amino acids) in the last 3 months.
* Concomitant endocrine, metabolic, degenerative, and/or chronic diseases other than obesity (eg diabetes, hyper/ hypercortisolemia, cardiovascular diseases, kidney diseases, myasthenia, neurological diseases, psychiatric disorders eg anorexia nervosa, cancer, anemia, celiac disease, chromosomal abnormalities eg syndrome Turner, Down, etc).
* Participation in any daily organized physical activity (sport), more than 1 hour per day.
* Presence of menstrual disorders in adolescent girls.
* Having any kind of nutrition/dietary intervention (eg weight loss diet, hypocaloric, ketogenic, low-protein diet), in the last 6 months.
For Controls:
* Presence of any form of thyroid disease.
* Presence of any endocrine, metabolic, degenerative, and/or chronic disease (eg diabetes, hyper/ hypercortisolemia, obesity, metabolic syndrome, cardiovascular diseases, kidney diseases, myasthenia, neurological diseases, psychiatric disorders eg anorexia nervosa, cancer, anemia, celiac disease, chromosomal abnormalities eg syndrome Turner, Down, etc).
* Taking any medication (eg growth hormone, corticosteroids) in the last 3 months.
* Taking food supplements (eg omega-3 fatty acids, amino acids) in the last 3 months.
* Participation in any daily organized physical activity (sport), more than 1 hour per day. Presence of menstrual disorders in adolescent girls.
* Having any kind of nutrition/dietary intervention (eg weight loss diet, hypocaloric, ketogenic, low-protein diet), in the last 6 months.
Minimum Eligible Age
5 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Sponsor Role
lead
Responsible Party
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Assimina Galli-Tsinopoulou
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Assimina Galli-Tsinopoulou, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
2nd Department of Paediatrics, AΗEPA Hospital
Locations
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2nd Department of Paediatrics, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA Hospital Thessaloniki, Greece
Thessaloniki, , Greece
Site Status
Countries
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Greece
References
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Adams AC, Astapova I, Fisher FM, Badman MK, Kurgansky KE, Flier JS, Hollenberg AN, Maratos-Flier E. Thyroid hormone regulates hepatic expression of fibroblast growth factor 21 in a PPARalpha-dependent manner. J Biol Chem. 2010 May 7;285(19):14078-82. doi: 10.1074/jbc.C110.107375. Epub 2010 Mar 17.
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BACKGROUND
Astrup A, Buemann B, Toubro S, Ranneries C, Raben A. Low resting metabolic rate in subjects predisposed to obesity: a role for thyroid status. Am J Clin Nutr. 1996 Jun;63(6):879-83. doi: 10.1093/ajcn/63.6.879.
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BACKGROUND
Barbesino G, Chiovato L. The genetics of Hashimoto's disease. Endocrinol Metab Clin North Am. 2000 Jun;29(2):357-74. doi: 10.1016/s0889-8529(05)70136-5.
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Coskun T, Bina HA, Schneider MA, Dunbar JD, Hu CC, Chen Y, Moller DE, Kharitonenkov A. Fibroblast growth factor 21 corrects obesity in mice. Endocrinology. 2008 Dec;149(12):6018-27. doi: 10.1210/en.2008-0816. Epub 2008 Aug 7.
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Dayan CM, Daniels GH. Chronic autoimmune thyroiditis. N Engl J Med. 1996 Jul 11;335(2):99-107. doi: 10.1056/NEJM199607113350206. No abstract available.
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Dostalova I, Kavalkova P, Haluzikova D, Lacinova Z, Mraz M, Papezova H, Haluzik M. Plasma concentrations of fibroblast growth factors 19 and 21 in patients with anorexia nervosa. J Clin Endocrinol Metab. 2008 Sep;93(9):3627-32. doi: 10.1210/jc.2008-0746. Epub 2008 Jun 17.
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Hanks LJ, Casazza K, Ashraf AP, Wallace S, Gutierrez OM. Fibroblast growth factor-21, body composition, and insulin resistance in pre-pubertal and early pubertal males and females. Clin Endocrinol (Oxf). 2015 Apr;82(4):550-6. doi: 10.1111/cen.12552. Epub 2014 Aug 8.
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Iglesias P, Selgas R, Romero S, Diez JJ. Biological role, clinical significance, and therapeutic possibilities of the recently discovered metabolic hormone fibroblastic growth factor 21. Eur J Endocrinol. 2012 Sep;167(3):301-9. doi: 10.1530/EJE-12-0357. Epub 2012 Jun 27.
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Kim KH, Lee MS. FGF21 as a Stress Hormone: The Roles of FGF21 in Stress Adaptation and the Treatment of Metabolic Diseases. Diabetes Metab J. 2014 Aug;38(4):245-51. doi: 10.4093/dmj.2014.38.4.245.
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Lee P, Linderman JD, Smith S, Brychta RJ, Wang J, Idelson C, Perron RM, Werner CD, Phan GQ, Kammula US, Kebebew E, Pacak K, Chen KY, Celi FS. Irisin and FGF21 are cold-induced endocrine activators of brown fat function in humans. Cell Metab. 2014 Feb 4;19(2):302-9. doi: 10.1016/j.cmet.2013.12.017.
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Lee Y, Park YJ, Ahn HY, Lim JA, Park KU, Choi SH, Park DJ, Oh BC, Jang HC, Yi KH. Plasma FGF21 levels are increased in patients with hypothyroidism independently of lipid profile. Endocr J. 2013;60(8):977-83. doi: 10.1507/endocrj.ej12-0427. Epub 2013 Jun 12.
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Mai K, Schwarz F, Bobbert T, Andres J, Assmann A, Pfeiffer AF, Spranger J. Relation between fibroblast growth factor-21, adiposity, metabolism, and weight reduction. Metabolism. 2011 Feb;60(2):306-11. doi: 10.1016/j.metabol.2010.02.016. Epub 2010 Apr 1.
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McAninch EA, Bianco AC. Thyroid hormone signaling in energy homeostasis and energy metabolism. Ann N Y Acad Sci. 2014 Apr;1311:77-87. doi: 10.1111/nyas.12374. Epub 2014 Feb 20.
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Pyrzak B, Demkow U, Kucharska AM. Brown Adipose Tissue and Browning Agents: Irisin and FGF21 in the Development of Obesity in Children and Adolescents. Adv Exp Med Biol. 2015;866:25-34. doi: 10.1007/5584_2015_149.
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Santini F, Marzullo P, Rotondi M, Ceccarini G, Pagano L, Ippolito S, Chiovato L, Biondi B. Mechanisms in endocrinology: the crosstalk between thyroid gland and adipose tissue: signal integration in health and disease. Eur J Endocrinol. 2014 Oct;171(4):R137-52. doi: 10.1530/EJE-14-0067.
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Vaidya B, Kendall-Taylor P, Pearce SH. The genetics of autoimmune thyroid disease. J Clin Endocrinol Metab. 2002 Dec;87(12):5385-97. doi: 10.1210/jc.2002-020492. No abstract available.
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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PEDIATRIC ENDOCRINOLOGY
Identifier Type: -
Identifier Source: org_study_id
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