Hashimoto DiseaseTHYROMETABOLNCT02725879
FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL)
An observational study of Hashimoto Disease, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hashimoto Disease
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2015to Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and Adolescents of Greek origin who attend the Pediatric Endocrinology Outpatient Units of 4th and 2nd Departments of Pediatrics, Medical School, Aristotle University of Thessaloniki for testing thyroid autoimmunity, as well as healthy controls.
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Paediatrics, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA Hospital Thessaloniki, Greece
Thessaloniki, 546 21
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Hashimoto Disease
- Keywords
- fibroblast growth factor 21, resting metabolic rate, chronic autoimmune thyroiditis, L-thyroxin, children, adolescents
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast Growth Factor 21 (FGF-21)
serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting
Measured: baseline and 6 months
RMR/Weight/Day
Resting Metabolic Rate (RMR) per kilogram of body weight per day
Measured: baseline and 6 months
Secondary outcomes (25)
SDS BMI
Standard Deviation Score (SDS) for Body Mass Index (BMI). The standard deviation is a measure of the amount of variation or spread of a set of values around the mean or average. The mean or average value is given an SDS of "0". A negative SDS indicates that the value is below the average or mean and a positive value means it is above the average or mean. SDS correspond to growth chart percentiles as follow:
-2.68 = 0.4th percentile, -2.01 = 2nd percentile, -1.34 = 9th percentile, -0.67 = 25th percentile, 0 (mean or average) = 50th percentile, +0.67 = 75th percentile, +1.34 = 91st percentile, +2.01 = 98th percentile, +2.68 = 99.6th percentile.
These percentiles help us understand whether a measurement falls within the normal range for children of the same age and sex. A lower SDS value (closer or lower to -2.68) and a higher SDS value (closer or above +2.68) mean a worst outcome, while a SDS value closer to 0 (mean or average), mean a better outcome.
Measured: baseline and 6 months
WAIST C.
Waist Circumference
Measured: baseline and 6 months
HIP C.
Hip circumference
Measured: baseline and 6 months
MUAC
mid-upper arm circumference
Measured: baseline and 6 months
%BF
Body fat percentage (%BF), is the total mass of fat divided by total body mass. The total body fat includes essential body fat and stored body fat.
Measured: baseline and 6 months
FMI
Fat mass index (FMI) is calculated by dividing the fat weight in kilograms by the height in metres squared.
Measured: baseline and 6 months
FFMI
Fat free mass index (FFMI) is calculated by dividing the free fat weight in kilograms by the height in metres squared.
Measured: baseline and 6 months
TSH
thyroid-stimulating hormone (TSH) after an overnight fasting
Measured: baseline and 6 months
FT3
free triiodothyronine after an overnight fasting
Measured: baseline and 6 months
FT4
free thyroxine (FT4) after an overnight fasting
Measured: baseline and 6 months
Glucose
glucose serum level after an overnight fasting
Measured: baseline and 6 months
Insulin
insulin serum level after an overnight fasting
Measured: baseline and 6 months
TC
Total Cholesterol (TC) serum level after an overnight fasting
Measured: baseline and 6 months
TG
Triglyceride (TG) serum level after an overnight fasting
Measured: baseline and 6 month
HDL
high-density lipoprotein (HDL) serum level after an overnight fasting
Measured: baseline and 6 months
LDL
low-density lipoprotein (LDL) serum level after an overnight fasting
Measured: baseline and 6 months
AST
aspartate aminotransferase (AST) serum level after an overnight fasting
Measured: baseline and 6 months
ALT
alanine aminotransferase (ALT) serum level after an overnight fasting
Measured: baseline and 6 months
γ-GT
gamma gloutamyltransferase (γ-GT) serum level after an overnight fasting
Measured: baseline and 6 months
ALP
alkaline phosphatase (ALP) serum level after an overnight fasting
Measured: baseline and 6 months
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR stands for Homeostatic Model Assessment of Insulin Resistance, using fasting insulin and blood glucose levels after an overnight fastιng. The meaningful part of the acronym is "insulin resistance". It marks for both the presence and extent of any insulin resistance that you might currently express. It is a way to reveal the dynamic between the baseline (fasting) blood sugar and the responsive hormone insulin.
Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Measured: baseline and 6 months
Mediterranean Diet Index (KIDMED) Score
Mediterranean diet index (KIDMED) score is a questionnaire used to evaluate adherence to the Mediterranean diet in children and adolescents. The KIDMED assesses how well an individual's dietary habits align with the Mediterranean diet.
Scoring System: 16 questions, each associated with a specific value. The total score ranges from -4 to 12.
Interpretation:
≤3: Very-low-quality diet. 4-7: Need to improve the food pattern to align with the Mediterranean diet.
≥8: Optimal adherence to the Mediterranean diet. A lower overall score (≤3) mean a worst outcome (adherence); while a higher overall score (≥8) mean a better outcome (adherence).
Measured: baseline
Mediterranean Diet Index (KIDMED) Analysis
specific foods frequency consumption based on the KIDMED questionnaire
Measured: baseline
Anti-TPOAb
antithyroid peroxidase antibody (Anti-TPOAb) titers
Measured: baseline and 6 months
Anti-TgAb
thyroglobulin antibody (Anti-TgAb) titers
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Hashimoto DiseaseStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki
- Investigators
- Assimina Galli-Tsinopoulou, MD,PhD, Principal investigator, 2nd Department of Paediatrics, AΗEPA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725879
- Sponsor's protocol ID
- PEDIATRIC ENDOCRINOLOGY
- Acronym
- THYROMETABOL
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2016
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20236931Astrup 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.
PubMed 8644681Barbesino 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.
PubMed 10874534Coskun 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.
PubMed 18687777Dayan CM, Daniels GH. Chronic autoimmune thyroiditis. N Engl J Med. 1996 Jul 11;335(2):99-107. doi: 10.1056/NEJM199607113350206. No abstract available.
PubMed 8649497Dostalova 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.
PubMed 18559909Griffiths M, Payne PR, Stunkard AJ, Rivers JP, Cox M. Metabolic rate and physical development in children at risk of obesity. Lancet. 1990 Jul 14;336(8707):76-8. doi: 10.1016/0140-6736(90)91592-x.
PubMed 1975323Hanks 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.
PubMed 25039824Iglesias 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.
PubMed 22740503Kim 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.
PubMed 25215270Lee 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.
PubMed 24506871Lee 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.
PubMed 23759753Mai 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.
PubMed 20362303McAninch 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.
PubMed 24697152Mraz M, Bartlova M, Lacinova Z, Michalsky D, Kasalicky M, Haluzikova D, Matoulek M, Dostalova I, Humenanska V, Haluzik M. Serum concentrations and tissue expression of a novel endocrine regulator fibroblast growth factor-21 in patients with type 2 diabetes and obesity. Clin Endocrinol (Oxf). 2009 Sep;71(3):369-75. doi: 10.1111/j.1365-2265.2008.03502.x. Epub 2008 Dec 11.
PubMed 19702724
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02725879
- Acronym / sponsor ID
- THYROMETABOL / PEDIATRIC ENDOCRINOLOGY
- Conditions
- Hashimoto Disease
- Keywords
- fibroblast growth factor 21, resting metabolic rate, chronic autoimmune thyroiditis, L-thyroxin, children, adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and Adolescents of Greek origin who attend the Pediatric Endocrinology Outpatient Units of 4th and 2nd Departments of Pediatrics, Medical School, Aristotle University of Thessaloniki for testing thyroid autoimmunity, as well as healthy controls.
Key inclusion criteria (6 listed)
- For patients
- Subjects 5 to 18 years old.
- First diagnosis of chronic autoimmune thyroiditis (high levels of serum antithyroid autoantibodies anti-TPO, anti-TgAb).
- Healthy individuals 5 to 18 years old.
- BMI for age between 15th and 85th percentile (z-score between -1 and +1).
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibroblast Growth Factor 21 (FGF-21)
Time frame: baseline and 6 months
serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting
RMR/Weight/Day
Time frame: baseline and 6 months
Resting Metabolic Rate (RMR) per kilogram of body weight per day
25 secondary outcomes
SDS BMI
Time frame: baseline and 6 months
WAIST C.
Time frame: baseline and 6 months
HIP C.
Time frame: baseline and 6 months
MUAC
Time frame: baseline and 6 months
%BF
Time frame: baseline and 6 months
FMI
Time frame: baseline and 6 months
FFMI
Time frame: baseline and 6 months
TSH
Time frame: baseline and 6 months
FT3
Time frame: baseline and 6 months
FT4
Time frame: baseline and 6 months
Glucose
Time frame: baseline and 6 months
Insulin
Time frame: baseline and 6 months
TC
Time frame: baseline and 6 months
TG
Time frame: baseline and 6 month
HDL
Time frame: baseline and 6 months
LDL
Time frame: baseline and 6 months
AST
Time frame: baseline and 6 months
ALT
Time frame: baseline and 6 months
γ-GT
Time frame: baseline and 6 months
ALP
Time frame: baseline and 6 months
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: baseline and 6 months
Mediterranean Diet Index (KIDMED) Score
Time frame: baseline
Mediterranean Diet Index (KIDMED) Analysis
Time frame: baseline
Anti-TPOAb
Time frame: baseline and 6 months
Anti-TgAb
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20236931Adams 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.
- Background: PubMed 8644681Astrup 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.
- Background: PubMed 10874534Barbesino 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.
- Background: PubMed 18687777Coskun 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.
- Background: PubMed 8649497Dayan CM, Daniels GH. Chronic autoimmune thyroiditis. N Engl J Med. 1996 Jul 11;335(2):99-107. doi: 10.1056/NEJM199607113350206. No abstract available.
- Background: PubMed 18559909Dostalova 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.
- Background: PubMed 1975323Griffiths M, Payne PR, Stunkard AJ, Rivers JP, Cox M. Metabolic rate and physical development in children at risk of obesity. Lancet. 1990 Jul 14;336(8707):76-8. doi: 10.1016/0140-6736(90)91592-x.
- Background: PubMed 25039824Hanks 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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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assimina Galli-Tsinopoulou, MD,PhD principal investigator
2nd Department of Paediatrics, AΗEPA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hashimoto Disease, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast Growth Factor 21 (FGF-21) (time frame: baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725879, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.