Hashimoto Disease
Conditions
Keywords
fibroblast growth factor 21, resting metabolic rate, chronic autoimmune thyroiditis, L-thyroxin, children, adolescents
Brief 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.
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.
Interventions
None listed
Sponsors
Aristotle University Of Thessaloniki
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibroblast Growth Factor 21 (FGF-21) | baseline and 6 months | serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting |
| RMR/Weight/Day | baseline and 6 months | Resting Metabolic Rate (RMR) per kilogram of body weight per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WAIST C. | baseline and 6 months | Waist Circumference |
| HIP C. | baseline and 6 months | Hip circumference |
| MUAC | baseline and 6 months | mid-upper arm circumference |
| %BF | baseline and 6 months | 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. |
| FMI | baseline and 6 months | Fat mass index (FMI) is calculated by dividing the fat weight in kilograms by the height in metres squared. |
| FFMI | baseline and 6 months | Fat free mass index (FFMI) is calculated by dividing the free fat weight in kilograms by the height in metres squared. |
| FT3 | baseline and 6 months | free triiodothyronine after an overnight fasting |
| FT4 | baseline and 6 months | free thyroxine (FT4) after an overnight fasting |
| Glucose | baseline and 6 months | glucose serum level after an overnight fasting |
| Insulin | baseline and 6 months | insulin serum level after an overnight fasting |
| TC | baseline and 6 months | Total Cholesterol (TC) serum level after an overnight fasting |
| TSH | baseline and 6 months | thyroid-stimulating hormone (TSH) after an overnight fasting |
| HDL | baseline and 6 months | high-density lipoprotein (HDL) serum level after an overnight fasting |
| LDL | baseline and 6 months | low-density lipoprotein (LDL) serum level after an overnight fasting |
| AST | baseline and 6 months | aspartate aminotransferase (AST) serum level after an overnight fasting |
| ALT | baseline and 6 months | alanine aminotransferase (ALT) serum level after an overnight fasting |
| γ-GT | baseline and 6 months | gamma gloutamyltransferase (γ-GT) serum level after an overnight fasting |
| ALP | baseline and 6 months | alkaline phosphatase (ALP) serum level after an overnight fasting |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | baseline and 6 months | 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. |
| Mediterranean Diet Index (KIDMED) Score | baseline | 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). |
| Mediterranean Diet Index (KIDMED) Analysis | baseline | specific foods frequency consumption based on the KIDMED questionnaire |
| Anti-TPOAb | baseline and 6 months | antithyroid peroxidase antibody (Anti-TPOAb) titers |
| Anti-TgAb | baseline and 6 months | thyroglobulin antibody (Anti-TgAb) titers |
| TG | baseline and 6 month | Triglyceride (TG) serum level after an overnight fasting |
| SDS BMI | baseline and 6 months | 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. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIT Subclinical Hypothyroid Group Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH), receiving standard levothyroxine (LT4) treatment. | 30 |
| Control Group Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group). | 30 |
| AIT Euthyroid Group Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group). | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | AIT Subclinical Hypothyroid Group | Control Group | AIT Euthyroid Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.99 years STANDARD_DEVIATION 1.85 | 10.89 years STANDARD_DEVIATION 2.29 | 11.01 years STANDARD_DEVIATION 1.93 | 10.97 years STANDARD_DEVIATION 2.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Region of Enrollment Greece | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 18 Participants | 54 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Fibroblast Growth Factor 21 (FGF-21)
serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group at the 6 month time point. Data have not been collected for the AIT Euthyroid Group for the baseline and 6 month time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Fibroblast Growth Factor 21 (FGF-21) | 6 months | 198.43 pg/mL |
| AIT Subclinical Hypothyroid Group | Fibroblast Growth Factor 21 (FGF-21) | baseline | 182.71 pg/mL |
| Control Group | Fibroblast Growth Factor 21 (FGF-21) | baseline | 217.36 pg/mL |
Primary
RMR/Weight/Day
Resting Metabolic Rate (RMR) per kilogram of body weight per day
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | RMR/Weight/Day | baseline | 131.08 kJ/kg/day |
| AIT Subclinical Hypothyroid Group | RMR/Weight/Day | 6 months | 142.51 kJ/kg/day |
| Control Group | RMR/Weight/Day | baseline | 150.46 kJ/kg/day |
| AIT Euthyroid Group | RMR/Weight/Day | baseline | 168.74 kJ/kg/day |
Secondary
ALP
alkaline phosphatase (ALP) serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | ALP | 6 months | 224.50 IU/L |
| AIT Subclinical Hypothyroid Group | ALP | baseline | 200.00 IU/L |
| Control Group | ALP | baseline | 217 IU/L |
| AIT Euthyroid Group | ALP | baseline | 217.00 IU/L |
Secondary
ALT
alanine aminotransferase (ALT) serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | ALT | baseline | 15.00 IU/L |
| AIT Subclinical Hypothyroid Group | ALT | 6 months | 15.50 IU/L |
| Control Group | ALT | baseline | 14.50 IU/L |
| AIT Euthyroid Group | ALT | baseline | 16.50 IU/L |
Secondary
Anti-TgAb
thyroglobulin antibody (Anti-TgAb) titers
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the baseline and 6 month time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Anti-TgAb | 6 months | 236.20 IU/mL |
| AIT Subclinical Hypothyroid Group | Anti-TgAb | baseline | 283.90 IU/mL |
Secondary
Anti-TPOAb
antithyroid peroxidase antibody (Anti-TPOAb) titers
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the baseline and 6 month time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Anti-TPOAb | baseline | 979.50 IU/mL |
| AIT Subclinical Hypothyroid Group | Anti-TPOAb | 6 months | 800.00 IU/mL |
Secondary
AST
aspartate aminotransferase (AST) serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | AST | baseline | 23.00 IU/L |
| AIT Subclinical Hypothyroid Group | AST | 6 months | 22.00 IU/L |
| Control Group | AST | baseline | 24.50 IU/L |
| AIT Euthyroid Group | AST | baseline | 27.50 IU/L |
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
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | %BF | baseline | 24.95 percentage of body fat |
| AIT Subclinical Hypothyroid Group | %BF | 6 months | 24.06 percentage of body fat |
| Control Group | %BF | baseline | 22.6 percentage of body fat |
| AIT Euthyroid Group | %BF | baseline | 21.65 percentage of body fat |
Secondary
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
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | FFMI | baseline | 14.27 kg/m^2 |
| AIT Subclinical Hypothyroid Group | FFMI | 6 months | 24.90 kg/m^2 |
| Control Group | FFMI | baseline | 14.66 kg/m^2 |
| AIT Euthyroid Group | FFMI | baseline | 13.47 kg/m^2 |
Secondary
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
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | FMI | baseline | 4.49 kg/m^2 |
| AIT Subclinical Hypothyroid Group | FMI | 6 months | 8.98 kg/m^2 |
| Control Group | FMI | baseline | 4.42 kg/m^2 |
| AIT Euthyroid Group | FMI | baseline | 4.12 kg/m^2 |
Secondary
FT3
free triiodothyronine after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | FT3 | baseline | 5.96 pmol/L |
| AIT Subclinical Hypothyroid Group | FT3 | 6 months | 5.90 pmol/L |
| Control Group | FT3 | baseline | 6.28 pmol/L |
| AIT Euthyroid Group | FT3 | baseline | 6.27 pmol/L |
Secondary
FT4
free thyroxine (FT4) after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIT Subclinical Hypothyroid Group | FT4 | baseline | 14.29 pmol/L | Standard Deviation 2.45 |
| AIT Subclinical Hypothyroid Group | FT4 | 6 months | 15.70 pmol/L | Standard Deviation 2.45 |
| Control Group | FT4 | baseline | 15.19 pmol/L | Standard Deviation 1.93 |
| AIT Euthyroid Group | FT4 | baseline | 15.19 pmol/L | Standard Deviation 2.57 |
Secondary
Glucose
glucose serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Glucose | baseline | 4.86 mmol/L |
| AIT Subclinical Hypothyroid Group | Glucose | 6 months | 4.97 mmol/L |
| Control Group | Glucose | baseline | 4.88 mmol/L |
| AIT Euthyroid Group | Glucose | baseline | 4.74 mmol/L |
Secondary
HDL
high-density lipoprotein (HDL) serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | HDL | baseline | 1.43 mmol/L |
| AIT Subclinical Hypothyroid Group | HDL | 6 months | 1.46 mmol/L |
| Control Group | HDL | baseline | 1.38 mmol/L |
| AIT Euthyroid Group | HDL | baseline | 1.54 mmol/L |
Secondary
HIP C.
Hip circumference
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIT Subclinical Hypothyroid Group | HIP C. | baseline | 81.38 cm | Standard Deviation 9.58 |
| AIT Subclinical Hypothyroid Group | HIP C. | 6 months | 81.50 cm | Standard Deviation 14.71 |
| Control Group | HIP C. | baseline | 80.63 cm | Standard Deviation 10.58 |
| AIT Euthyroid Group | HIP C. | baseline | 77.41 cm | Standard Deviation 9.69 |
Secondary
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
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | baseline | 1.93 index |
| AIT Subclinical Hypothyroid Group | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | 6 months | 1.90 index |
| Control Group | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | baseline | 1.50 index |
| AIT Euthyroid Group | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | baseline | 1.62 index |
Secondary
Insulin
insulin serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Insulin | baseline | 64.58 pmol/L |
| AIT Subclinical Hypothyroid Group | Insulin | 6 months | 65.07 pmol/L |
| Control Group | Insulin | baseline | 48.12 pmol/L |
| AIT Euthyroid Group | Insulin | baseline | 54.65 pmol/L |
Secondary
LDL
low-density lipoprotein (LDL) serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | LDL | baseline | 2.30 mmol/L |
| AIT Subclinical Hypothyroid Group | LDL | 6 months | 2.30 mmol/L |
| Control Group | LDL | baseline | 2.07 mmol/L |
| AIT Euthyroid Group | LDL | baseline | 2.33 mmol/L |
Secondary
Mediterranean Diet Index (KIDMED) Analysis
specific foods frequency consumption based on the KIDMED questionnaire
Time frame: baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Dairy at breakfast | 24 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | 2 Yogurt - cheese servings daily | 19 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fish regularly > 2 per week | 9 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | 1 Fresh - cooked vegetable daily | 18 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | 1 Fruit - fruit juice daily | 16 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fresh - cooked vegetable daily >1 | 6 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fruits daily >2 | 7 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Olive oil daily | 29 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fast food >1 per week | 12 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Sweets and candies daily | 23 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Nuts > 2 times per week | 9 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Legumes >1 per week | 20 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Cereals - grains daily | 28 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Skipping breakfast | 7 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Commercial pastries - pastries at breakfast | 18 Participants |
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Pasta - rice daily | 25 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | 1 Fresh - cooked vegetable daily | 18 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Fresh - cooked vegetable daily >1 | 10 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Fish regularly > 2 per week | 15 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Fast food >1 per week | 5 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Skipping breakfast | 6 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | 2 Yogurt - cheese servings daily | 18 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | 1 Fruit - fruit juice daily | 22 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Fruits daily >2 | 13 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Legumes >1 per week | 17 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Pasta - rice daily | 23 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Cereals - grains daily | 29 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Nuts > 2 times per week | 14 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Olive oil daily | 28 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Dairy at breakfast | 25 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Commercial pastries - pastries at breakfast | 13 Participants |
| Control Group | Mediterranean Diet Index (KIDMED) Analysis | Sweets and candies daily | 17 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Olive oil daily | 29 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fresh - cooked vegetable daily >1 | 5 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Cereals - grains daily | 27 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fast food >1 per week | 9 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Sweets and candies daily | 22 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Nuts > 2 times per week | 8 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fish regularly > 2 per week | 16 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | 1 Fruit - fruit juice daily | 20 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Commercial pastries - pastries at breakfast | 16 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Fruits daily >2 | 12 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | 2 Yogurt - cheese servings daily | 20 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | 1 Fresh - cooked vegetable daily | 22 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Legumes >1 per week | 21 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Skipping breakfast | 9 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Dairy at breakfast | 26 Participants |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Analysis | Pasta - rice daily | 23 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | Mediterranean Diet Index (KIDMED) Score | 6.37 index | Standard Deviation 2.67 |
| Control Group | Mediterranean Diet Index (KIDMED) Score | 5.77 index | Standard Deviation 2.78 |
| AIT Euthyroid Group | Mediterranean Diet Index (KIDMED) Score | 5.00 index | Standard Deviation 2 |
Secondary
MUAC
mid-upper arm circumference
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | MUAC | baseline | 22.00 cm |
| AIT Subclinical Hypothyroid Group | MUAC | 6 months | 23.00 cm |
| Control Group | MUAC | baseline | 23.00 cm |
| AIT Euthyroid Group | MUAC | baseline | 21.00 cm |
Secondary
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
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | SDS BMI | baseline | 0.73 score on a scale |
| AIT Subclinical Hypothyroid Group | SDS BMI | 6 months | 0.88 score on a scale |
| Control Group | SDS BMI | baseline | 0.88 score on a scale |
| AIT Euthyroid Group | SDS BMI | baseline | 0.36 score on a scale |
Secondary
TC
Total Cholesterol (TC) serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIT Subclinical Hypothyroid Group | TC | 6 months | 4.19 mmol/L | Standard Deviation 0.86 |
| AIT Subclinical Hypothyroid Group | TC | baseline | 4.22 mmol/L | Standard Deviation 0.84 |
| Control Group | TC | baseline | 3.88 mmol/L | Standard Deviation 0.75 |
| AIT Euthyroid Group | TC | baseline | 4.22 mmol/L | Standard Deviation 0.69 |
Secondary
TG
Triglyceride (TG) serum level after an overnight fasting
Time frame: baseline and 6 month
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | TG | 6 months | 0.73 mmol/L |
| AIT Subclinical Hypothyroid Group | TG | baseline | 0.74 mmol/L |
| Control Group | TG | baseline | 0.52 mmol/L |
| AIT Euthyroid Group | TG | baseline | 0.66 mmol/L |
Secondary
TSH
thyroid-stimulating hormone (TSH) after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | TSH | baseline | 4.82 μIU/L |
| AIT Subclinical Hypothyroid Group | TSH | 6 months | 4.03 μIU/L |
| Control Group | TSH | baseline | 2.40 μIU/L |
| AIT Euthyroid Group | TSH | baseline | 2.63 μIU/L |
Secondary
WAIST C.
Waist Circumference
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIT Subclinical Hypothyroid Group | WAIST C. | baseline | 67.73 cm | Standard Deviation 9.32 |
| AIT Subclinical Hypothyroid Group | WAIST C. | 6 months | 69.2 cm | Standard Deviation 8.61 |
| Control Group | WAIST C. | baseline | 69.33 cm | Standard Deviation 9.99 |
| AIT Euthyroid Group | WAIST C. | baseline | 65.65 cm | Standard Deviation 8.59 |
Secondary
γ-GT
gamma gloutamyltransferase (γ-GT) serum level after an overnight fasting
Time frame: baseline and 6 months
Population: Data have not been collected for the Control Group and AIT Euthyroid Group for the 6 month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AIT Subclinical Hypothyroid Group | γ-GT | baseline | 12.00 IU/L |
| AIT Subclinical Hypothyroid Group | γ-GT | 6 months | 11.00 IU/L |
| Control Group | γ-GT | baseline | 12.00 IU/L |
| AIT Euthyroid Group | γ-GT | baseline | 12.00 IU/L |