CompletedNCT02725879THYROMETABOLUpdated Feb 20, 2024Results posted

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

An observational study in Hashimoto Disease, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type: Observational
Model: Other
Time perspective: Cross-sectional
Enrollment: 90
Ages: 5 Years to 18 Years
Sex: All

Study 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. 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 studied

Hashimoto Disease

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Keywords

fibroblast growth factor 21
resting metabolic rate
chronic autoimmune thyroiditis
L-thyroxin
children
adolescents

Who can participate

Ages eligible: 5 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

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.

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).

Exclusion criteria

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.

Study design

Observational model: Other
Time perspective: Cross-sectional
Enrollment: 90 participants (actual)
Patient registry: No
Biospecimen retention: None retained

Groups and cohorts

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 researchers measure

Primary outcomes

Fibroblast Growth Factor 21 (FGF-21)
serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting
Time frame: baseline and 6 months
RMR/Weight/Day
Resting Metabolic Rate (RMR) per kilogram of body weight per day
Time frame: baseline and 6 months

Secondary outcomes

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.
Time frame: baseline and 6 months
WAIST C.
Waist Circumference
Time frame: baseline and 6 months
HIP C.
Hip circumference
Time frame: baseline and 6 months
MUAC
mid-upper arm circumference
Time frame: 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.
Time frame: baseline and 6 months
FMI
Fat mass index (FMI) is calculated by dividing the fat weight in kilograms by the height in metres squared.
Time frame: 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.
Time frame: baseline and 6 months
TSH
thyroid-stimulating hormone (TSH) after an overnight fasting
Time frame: baseline and 6 months
FT3
free triiodothyronine after an overnight fasting
Time frame: baseline and 6 months
FT4
free thyroxine (FT4) after an overnight fasting
Time frame: baseline and 6 months
Glucose
glucose serum level after an overnight fasting
Time frame: baseline and 6 months
Insulin
insulin serum level after an overnight fasting
Time frame: baseline and 6 months
TC
Total Cholesterol (TC) serum level after an overnight fasting
Time frame: baseline and 6 months
TG
Triglyceride (TG) serum level after an overnight fasting
Time frame: baseline and 6 month
HDL
high-density lipoprotein (HDL) serum level after an overnight fasting
Time frame: baseline and 6 months
LDL
low-density lipoprotein (LDL) serum level after an overnight fasting
Time frame: baseline and 6 months
AST
aspartate aminotransferase (AST) serum level after an overnight fasting
Time frame: baseline and 6 months
ALT
alanine aminotransferase (ALT) serum level after an overnight fasting
Time frame: baseline and 6 months
γ-GT
gamma gloutamyltransferase (γ-GT) serum level after an overnight fasting
Time frame: baseline and 6 months
ALP
alkaline phosphatase (ALP) serum level after an overnight fasting
Time frame: 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.
Time frame: 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).
Time frame: baseline
Mediterranean Diet Index (KIDMED) Analysis
specific foods frequency consumption based on the KIDMED questionnaire
Time frame: baseline
Anti-TPOAb
antithyroid peroxidase antibody (Anti-TPOAb) titers
Time frame: baseline and 6 months
Anti-TgAb
thyroglobulin antibody (Anti-TgAb) titers
Time frame: baseline and 6 months

Results

Posted Feb 20, 2024

Limitations and caveats

No randomization; relative small sample size; serum FGF-21 levels were not measured in AIT euthyroid patients, as previous animal studies revealed that exogenous FGF-21 administration to hypothyroid animal models led to similar serum and liver lipid metabolites and gene expression changes in both hypothyroid and euthyroid mice. Patients did not have severe long-standing hypothyroidism.

Participant flow

Participant flow — Overall Study
Milestone	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
Started	30	30	30
Completed	30	30	30
Not completed	0	0	0

Outcome measures

PrimaryFibroblast Growth Factor 21 (FGF-21)

serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · pg/mL

Fibroblast Growth Factor 21 (FGF-21)
pg/mL	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	182.71 (169.32 to 234.55)	217.36 (193.60 to 235.21)	—
6 months	198.43 (183.86 to 248.42)	—	—

PrimaryRMR/Weight/Day

Resting Metabolic Rate (RMR) per kilogram of body weight per day

Time frame:: baseline and 6 months
Reported as:: Median · kJ/kg/day

RMR/Weight/Day
kJ/kg/day	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	131.08 (108.62 to 165.10)	150.46 (122.09 to 190.58)	168.74 (133.26 to 193.51)
6 months	142.51 (116.61 to 168.53)	—	—

SecondarySDS 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.

Time frame:: baseline and 6 months
Reported as:: Median · score on a scale

SDS BMI
score on a scale	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	0.73 (0.12 to 1.64)	0.88 (-0.01 to 1.22)	0.36 (-1.07 to 1.16)
6 months	0.88 (0.10 to 1.50)	—	—

SecondaryWAIST C.

Waist Circumference

Time frame:: baseline and 6 months
Reported as:: Mean · cm

WAIST C.
cm	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	67.73 ± 9.32	69.33 ± 9.99	65.65 ± 8.59
6 months	69.2 ± 8.61	—	—

SecondaryHIP C.

Hip circumference

Time frame:: baseline and 6 months
Reported as:: Mean · cm

HIP C.
cm	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	81.38 ± 9.58	80.63 ± 10.58	77.41 ± 9.69
6 months	81.50 ± 14.71	—	—

SecondaryMUAC

mid-upper arm circumference

Time frame:: baseline and 6 months
Reported as:: Median · cm

MUAC
cm	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	22.00 (20.00 to 25.25)	23.00 (20.00 to 25.25)	21.00 (19.75 to 23.62)
6 months	23.00 (22.00 to 26.00)	—	—

Secondary%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.

Time frame:: baseline and 6 months
Reported as:: Median · percentage of body fat

%BF
percentage of body fat	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	24.95 (21.15 to 32.07)	22.6 (18.53 to 31.8)	21.65 (16.47 to 29.83)
6 months	24.06 (19.27 to 31.16)	—	—

SecondaryFMI

Fat mass index (FMI) is calculated by dividing the fat weight in kilograms by the height in metres squared.

Time frame:: baseline and 6 months
Reported as:: Median · kg/m^2

FMI
kg/m^2	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	4.49 (3.43 to 7.06)	4.42 (3.17 to 5.98)	4.12 (2.64 to 5.63)
6 months	8.98 (4.87 to 13.4)	—	—

SecondaryFFMI

Fat free mass index (FFMI) is calculated by dividing the free fat weight in kilograms by the height in metres squared.

Time frame:: baseline and 6 months
Reported as:: Median · kg/m^2

FFMI
kg/m^2	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	14.27 (13.50 to 14.63)	14.66 (13.43 to 15.31)	13.47 (12.69 to 14.58)
6 months	24.90 (18.52 to 31.31)	—	—

SecondaryTSH

thyroid-stimulating hormone (TSH) after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · μIU/L

TSH
μIU/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	4.82 (3.99 to 9.66)	2.40 (1.95 to 3.06)	2.63 (2.13 to 3.09)
6 months	4.03 (2.43 to 6.20)	—	—

SecondaryFT3

free triiodothyronine after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · pmol/L

FT3
pmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	5.96 (5.44 to 6.44)	6.28 (5.71 to 6.79)	6.27 (5.91 to 6.71)
6 months	5.90 (5.22 to 6.21)	—	—

SecondaryFT4

free thyroxine (FT4) after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Mean · pmol/L

FT4
pmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	14.29 ± 2.45	15.19 ± 1.93	15.19 ± 2.57
6 months	15.70 ± 2.45	—	—

SecondaryGlucose

glucose serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · mmol/L

Glucose
mmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	4.86 (4.66 to 5.12)	4.88 (4.65 to 5.11)	4.74 (4.49 to 5.05)
6 months	4.97 (4.72 to 5.19)	—	—

SecondaryInsulin

insulin serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · pmol/L

Insulin
pmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	64.58 (46.46 to 86.87)	48.12 (37.36 to 81.32)	54.65 (33.96 to 81.87)
6 months	65.07 (47.85 to 87.43)	—	—

SecondaryTC

Total Cholesterol (TC) serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Mean · mmol/L

TC
mmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	4.22 ± 0.84	3.88 ± 0.75	4.22 ± 0.69
6 months	4.19 ± 0.86	—	—

SecondaryTG

Triglyceride (TG) serum level after an overnight fasting

Time frame:: baseline and 6 month
Reported as:: Median · mmol/L

TG
mmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	0.74 (0.52 to 0.89)	0.52 (0.45 to 0.65)	0.66 (0.56 to 1.02)
6 months	0.73 (0.56 to 0.93)	—	—

SecondaryHDL

high-density lipoprotein (HDL) serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · mmol/L

HDL
mmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	1.43 (1.18 to 1.65)	1.38 (1.23 to 1.63)	1.54 (1.24 to 1.99)
6 months	1.46 (1.26 to 1.61)	—	—

SecondaryLDL

low-density lipoprotein (LDL) serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · mmol/L

LDL
mmol/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	2.30 (2.01 to 2.92)	2.07 (1.65 to 2.56)	2.33 (2.04 to 2.64)
6 months	2.30 (1.93 to 2.82)	—	—

SecondaryAST

aspartate aminotransferase (AST) serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · IU/L

AST
IU/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	23.00 (19.00 to 25.25)	24.50 (18.75 to 28.25)	27.50 (23.75 to 29.00)
6 months	22.00 (18.00 to 25.00)	—	—

SecondaryALT

alanine aminotransferase (ALT) serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · IU/L

ALT
IU/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	15.00 (13.00 to 19.50)	14.50 (13.00 to 18.00)	16.50 (13.75 to 19.00)
6 months	15.50 (13.75 to 19.25)	—	—

Secondaryγ-GT

gamma gloutamyltransferase (γ-GT) serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · IU/L

γ-GT
IU/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	12.00 (10.75 to 15.00)	12.00 (10.00 to 13.25)	12.00 (11.00 to 13.25)
6 months	11.00 (10.00 to 14.00)	—	—

SecondaryALP

alkaline phosphatase (ALP) serum level after an overnight fasting

Time frame:: baseline and 6 months
Reported as:: Median · IU/L

ALP
IU/L	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	200.00 (157.75 to 291.50)	217 (149.5 to 275.50)	217.00 (183.25 to 275.00)
6 months	224.50 (162.50 to 270.25)	—	—

SecondaryHomeostatic 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.

Time frame:: baseline and 6 months
Reported as:: Median · index

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
index	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	1.93 (1.39 to 2.72)	1.50 (1.11 to 2.54)	1.62 (1.02 to 2.52)
6 months	1.90 (1.57 to 2.65)	—	—

SecondaryMediterranean 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).

Time frame:: baseline
Reported as:: Mean · index

Mediterranean Diet Index (KIDMED) Score
index	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
Mediterranean Diet Index (KIDMED) Score	6.37 ± 2.67	5.77 ± 2.78	5.00 ± 2.00

SecondaryMediterranean Diet Index (KIDMED) Analysis

specific foods frequency consumption based on the KIDMED questionnaire

Time frame:: baseline
Reported as:: Count of participants · Participants

Mediterranean Diet Index (KIDMED) Analysis
Participants	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
1 Fruit - fruit juice daily	16	22	20
Fruits daily >2	7	13	12
1 Fresh - cooked vegetable daily	18	18	22
Fresh - cooked vegetable daily >1	6	10	5
Fish regularly > 2 per week	9	15	16
Fast food >1 per week	12	5	9
Legumes >1 per week	20	17	21
Pasta - rice daily	25	23	23
Cereals - grains daily	28	29	27
Nuts > 2 times per week	9	14	8
Olive oil daily	29	28	29
Skipping breakfast	7	6	9
Dairy at breakfast	24	25	26
Commercial pastries - pastries at breakfast	18	13	16
2 Yogurt - cheese servings daily	19	18	20
Sweets and candies daily	23	17	22

SecondaryAnti-TPOAb

antithyroid peroxidase antibody (Anti-TPOAb) titers

Time frame:: baseline and 6 months
Reported as:: Median · IU/mL

Anti-TPOAb
IU/mL	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	979.50 (135.27 to 2383.72)	—	—
6 months	800.00 (73.47 to 1687.20)	—	—

SecondaryAnti-TgAb

thyroglobulin antibody (Anti-TgAb) titers

Time frame:: baseline and 6 months
Reported as:: Median · IU/mL

Anti-TgAb
IU/mL	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group
baseline	283.90 (69.40 to 500.00)	—	—
6 months	236.20 (87.95 to 500.00)	—	—

Adverse events

Collected over 0. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AIT Subclinical Hypothyroid Group	—	—	—
Control Group	—	—	—
AIT Euthyroid Group	—	—	—

Baseline characteristics

AIT Subclinical Hypothyroid group: diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH), receiving standard levothyroxine (LT4) treatment. Control group: Healthy, no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group). AIT Euthyroid group: diagnosed with chronic autoimmune thyroiditis (AIT) and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).

Age, Categorical
Age, Categorical(Participants)	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group	Total
<=18 years	30	30	30	90
Between 18 and 65 years	0	0	0	0
>=65 years	0	0	0	0

Age, Continuous
Age, Continuous(years)	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group	Total
Mean	10.99 ± 1.85	10.89 ± 2.29	11.01 ± 1.93	10.97 ± 2.02

Sex: Female, Male
Sex: Female, Male(Participants)	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group	Total
Female	18	18	18	54
Male	12	12	12	36

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group	Total
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	30	30	30	90
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	30	30	30	90
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	AIT Subclinical Hypothyroid Group	Control Group	AIT Euthyroid Group	Total
Greece	30	30	30	90

Study locations

1 site

2nd Department of Paediatrics, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA Hospital Thessaloniki, Greece
Thessaloniki, 546 21, Greece

References and documents

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 20236931 ↗
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. PubMed 8644681 ↗
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. PubMed 10874534 ↗
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. PubMed 18687777 ↗
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. PubMed 8649497 ↗
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. PubMed 18559909 ↗
Griffiths 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 1975323 ↗
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. PubMed 25039824 ↗
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. PubMed 22740503 ↗
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. PubMed 25215270 ↗
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. PubMed 24506871 ↗
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. PubMed 23759753 ↗
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. PubMed 20362303 ↗
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. PubMed 24697152 ↗
Mraz 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 ↗
Muller TD, Tschop MH. Play down protein to play up metabolism? J Clin Invest. 2014 Sep;124(9):3691-3. doi: 10.1172/JCI77508. Epub 2014 Aug 18. PubMed 25133420 ↗
Nakamura MT, Yudell BE, Loor JJ. Regulation of energy metabolism by long-chain fatty acids. Prog Lipid Res. 2014 Jan;53:124-44. doi: 10.1016/j.plipres.2013.12.001. Epub 2013 Dec 18. PubMed 24362249 ↗
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. PubMed 26022904 ↗
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. PubMed 25214234 ↗
Skarpa V, Kousta E, Tertipi A, Anyfandakis K, Vakaki M, Dolianiti M, Fotinou A, Papathanasiou A. Epidemiological characteristics of children with autoimmune thyroid disease. Hormones (Athens). 2011 Jul-Sep;10(3):207-14. doi: 10.14310/horm.2002.1310. PubMed 22001131 ↗
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. PubMed 12466323 ↗
Woelnerhanssen B, Peterli R, Steinert RE, Peters T, Borbely Y, Beglinger C. Effects of postbariatric surgery weight loss on adipokines and metabolic parameters: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy--a prospective randomized trial. Surg Obes Relat Dis. 2011 Sep-Oct;7(5):561-8. doi: 10.1016/j.soard.2011.01.044. Epub 2011 Mar 22. PubMed 21429816 ↗
Xu J, Lloyd DJ, Hale C, Stanislaus S, Chen M, Sivits G, Vonderfecht S, Hecht R, Li YS, Lindberg RA, Chen JL, Jung DY, Zhang Z, Ko HJ, Kim JK, Veniant MM. Fibroblast growth factor 21 reverses hepatic steatosis, increases energy expenditure, and improves insulin sensitivity in diet-induced obese mice. Diabetes. 2009 Jan;58(1):250-9. doi: 10.2337/db08-0392. Epub 2008 Oct 7. PubMed 18840786 ↗
Zhang A, Sieglaff DH, York JP, Suh JH, Ayers SD, Winnier GE, Kharitonenkov A, Pin C, Zhang P, Webb P, Xia X. Thyroid hormone receptor regulates most genes independently of fibroblast growth factor 21 in liver. J Endocrinol. 2015 Mar;224(3):289-301. doi: 10.1530/JOE-14-0440. Epub 2014 Dec 11. PubMed 25501997 ↗

Study documents

Protocol, analysis plan and consent form · Oct 1, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT02725879
Lead sponsor: Aristotle University Of Thessaloniki
Responsible party: Assimina Galli-Tsinopoulou (Professor, Aristotle University Of Thessaloniki) — Principal investigator
First posted: Apr 1, 2016
Start date: Oct 2015
Primary completion: Mar 2020
Completion: Mar 2020
Results posted: Feb 20, 2024
Last update: Feb 20, 2024

Study contacts

Assimina Galli-Tsinopoulou, MD,PhD

principal investigator · 2nd Department of Paediatrics, AΗEPA Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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