Trial Outcomes & Findings for FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL) (NCT NCT02725879)
NCT ID: NCT02725879
Last Updated: 2024-02-20
Results Overview
serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting
Recruitment status
COMPLETED
Target enrollment
90 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
AIT Subclinical Hypothyroid Group
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH), who received standard levothyroxine (LT4) treatment.
|
Control Group
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Treatment Group).
|
AIT Euthyroid Group
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL)
Baseline characteristics by cohort
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH), receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
10.99 years
STANDARD_DEVIATION 1.85 • n=5 Participants
|
10.89 years
STANDARD_DEVIATION 2.29 • n=7 Participants
|
11.01 years
STANDARD_DEVIATION 1.93 • n=5 Participants
|
10.97 years
STANDARD_DEVIATION 2.02 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
90 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: 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.
serum fibroblast growth factor 21 (FGF-21) levels after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Fibroblast Growth Factor 21 (FGF-21)
baseline
|
182.71 pg/mL
Interval 169.32 to 234.55
|
217.36 pg/mL
Interval 193.6 to 235.21
|
—
|
|
Fibroblast Growth Factor 21 (FGF-21)
6 months
|
198.43 pg/mL
Interval 183.86 to 248.42
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
Resting Metabolic Rate (RMR) per kilogram of body weight per day
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
RMR/Weight/Day
baseline
|
131.08 kJ/kg/day
Interval 108.62 to 165.1
|
150.46 kJ/kg/day
Interval 122.09 to 190.58
|
168.74 kJ/kg/day
Interval 133.26 to 193.51
|
|
RMR/Weight/Day
6 months
|
142.51 kJ/kg/day
Interval 116.61 to 168.53
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
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.
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
SDS BMI
baseline
|
0.73 score on a scale
Interval 0.12 to 1.64
|
0.88 score on a scale
Interval -0.01 to 1.22
|
0.36 score on a scale
Interval -1.07 to 1.16
|
|
SDS BMI
6 months
|
0.88 score on a scale
Interval 0.1 to 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
Waist Circumference
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
WAIST C.
baseline
|
67.73 cm
Standard Deviation 9.32
|
69.33 cm
Standard Deviation 9.99
|
65.65 cm
Standard Deviation 8.59
|
|
WAIST C.
6 months
|
69.2 cm
Standard Deviation 8.61
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
Hip circumference
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
HIP C.
baseline
|
81.38 cm
Standard Deviation 9.58
|
80.63 cm
Standard Deviation 10.58
|
77.41 cm
Standard Deviation 9.69
|
|
HIP C.
6 months
|
81.50 cm
Standard Deviation 14.71
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
mid-upper arm circumference
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
MUAC
baseline
|
22.00 cm
Interval 20.0 to 25.25
|
23.00 cm
Interval 20.0 to 25.25
|
21.00 cm
Interval 19.75 to 23.62
|
|
MUAC
6 months
|
23.00 cm
Interval 22.0 to 26.0
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
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.
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
%BF
baseline
|
24.95 percentage of body fat
Interval 21.15 to 32.07
|
22.6 percentage of body fat
Interval 18.53 to 31.8
|
21.65 percentage of body fat
Interval 16.47 to 29.83
|
|
%BF
6 months
|
24.06 percentage of body fat
Interval 19.27 to 31.16
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
Fat mass index (FMI) is calculated by dividing the fat weight in kilograms by the height in metres squared.
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
FMI
baseline
|
4.49 kg/m^2
Interval 3.43 to 7.06
|
4.42 kg/m^2
Interval 3.17 to 5.98
|
4.12 kg/m^2
Interval 2.64 to 5.63
|
|
FMI
6 months
|
8.98 kg/m^2
Interval 4.87 to 13.4
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
Fat free mass index (FFMI) is calculated by dividing the free fat weight in kilograms by the height in metres squared.
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
FFMI
baseline
|
14.27 kg/m^2
Interval 13.5 to 14.63
|
14.66 kg/m^2
Interval 13.43 to 15.31
|
13.47 kg/m^2
Interval 12.69 to 14.58
|
|
FFMI
6 months
|
24.90 kg/m^2
Interval 18.52 to 31.31
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
thyroid-stimulating hormone (TSH) after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
TSH
baseline
|
4.82 μIU/L
Interval 3.99 to 9.66
|
2.40 μIU/L
Interval 1.95 to 3.06
|
2.63 μIU/L
Interval 2.13 to 3.09
|
|
TSH
6 months
|
4.03 μIU/L
Interval 2.43 to 6.2
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
free triiodothyronine after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
FT3
baseline
|
5.96 pmol/L
Interval 5.44 to 6.44
|
6.28 pmol/L
Interval 5.71 to 6.79
|
6.27 pmol/L
Interval 5.91 to 6.71
|
|
FT3
6 months
|
5.90 pmol/L
Interval 5.22 to 6.21
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
free thyroxine (FT4) after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
FT4
baseline
|
14.29 pmol/L
Standard Deviation 2.45
|
15.19 pmol/L
Standard Deviation 1.93
|
15.19 pmol/L
Standard Deviation 2.57
|
|
FT4
6 months
|
15.70 pmol/L
Standard Deviation 2.45
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
glucose serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Glucose
baseline
|
4.86 mmol/L
Interval 4.66 to 5.12
|
4.88 mmol/L
Interval 4.65 to 5.11
|
4.74 mmol/L
Interval 4.49 to 5.05
|
|
Glucose
6 months
|
4.97 mmol/L
Interval 4.72 to 5.19
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
insulin serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Insulin
baseline
|
64.58 pmol/L
Interval 46.46 to 86.87
|
48.12 pmol/L
Interval 37.36 to 81.32
|
54.65 pmol/L
Interval 33.96 to 81.87
|
|
Insulin
6 months
|
65.07 pmol/L
Interval 47.85 to 87.43
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
Total Cholesterol (TC) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
TC
baseline
|
4.22 mmol/L
Standard Deviation 0.84
|
3.88 mmol/L
Standard Deviation 0.75
|
4.22 mmol/L
Standard Deviation 0.69
|
|
TC
6 months
|
4.19 mmol/L
Standard Deviation 0.86
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
Triglyceride (TG) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
TG
baseline
|
0.74 mmol/L
Interval 0.52 to 0.89
|
0.52 mmol/L
Interval 0.45 to 0.65
|
0.66 mmol/L
Interval 0.56 to 1.02
|
|
TG
6 months
|
0.73 mmol/L
Interval 0.56 to 0.93
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
high-density lipoprotein (HDL) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
HDL
baseline
|
1.43 mmol/L
Interval 1.18 to 1.65
|
1.38 mmol/L
Interval 1.23 to 1.63
|
1.54 mmol/L
Interval 1.24 to 1.99
|
|
HDL
6 months
|
1.46 mmol/L
Interval 1.26 to 1.61
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
low-density lipoprotein (LDL) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
LDL
baseline
|
2.30 mmol/L
Interval 2.01 to 2.92
|
2.07 mmol/L
Interval 1.65 to 2.56
|
2.33 mmol/L
Interval 2.04 to 2.64
|
|
LDL
6 months
|
2.30 mmol/L
Interval 1.93 to 2.82
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
aspartate aminotransferase (AST) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
AST
baseline
|
23.00 IU/L
Interval 19.0 to 25.25
|
24.50 IU/L
Interval 18.75 to 28.25
|
27.50 IU/L
Interval 23.75 to 29.0
|
|
AST
6 months
|
22.00 IU/L
Interval 18.0 to 25.0
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
alanine aminotransferase (ALT) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
ALT
baseline
|
15.00 IU/L
Interval 13.0 to 19.5
|
14.50 IU/L
Interval 13.0 to 18.0
|
16.50 IU/L
Interval 13.75 to 19.0
|
|
ALT
6 months
|
15.50 IU/L
Interval 13.75 to 19.25
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
gamma gloutamyltransferase (γ-GT) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
γ-GT
baseline
|
12.00 IU/L
Interval 10.75 to 15.0
|
12.00 IU/L
Interval 10.0 to 13.25
|
12.00 IU/L
Interval 11.0 to 13.25
|
|
γ-GT
6 months
|
11.00 IU/L
Interval 10.0 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
alkaline phosphatase (ALP) serum level after an overnight fasting
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
ALP
baseline
|
200.00 IU/L
Interval 157.75 to 291.5
|
217 IU/L
Interval 149.5 to 275.5
|
217.00 IU/L
Interval 183.25 to 275.0
|
|
ALP
6 months
|
224.50 IU/L
Interval 162.5 to 270.25
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the 6 month time point.
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.
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
baseline
|
1.93 index
Interval 1.39 to 2.72
|
1.50 index
Interval 1.11 to 2.54
|
1.62 index
Interval 1.02 to 2.52
|
|
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
6 months
|
1.90 index
Interval 1.57 to 2.65
|
—
|
—
|
SECONDARY outcome
Timeframe: baselineMediterranean 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).
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Mediterranean Diet Index (KIDMED) Score
|
6.37 index
Standard Deviation 2.67
|
5.77 index
Standard Deviation 2.78
|
5.00 index
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: baselinespecific foods frequency consumption based on the KIDMED questionnaire
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
n=30 Participants
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
n=30 Participants
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Mediterranean Diet Index (KIDMED) Analysis
1 Fruit - fruit juice daily
|
16 Participants
|
22 Participants
|
20 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Fruits daily >2
|
7 Participants
|
13 Participants
|
12 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
1 Fresh - cooked vegetable daily
|
18 Participants
|
18 Participants
|
22 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Fresh - cooked vegetable daily >1
|
6 Participants
|
10 Participants
|
5 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Fish regularly > 2 per week
|
9 Participants
|
15 Participants
|
16 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Fast food >1 per week
|
12 Participants
|
5 Participants
|
9 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Legumes >1 per week
|
20 Participants
|
17 Participants
|
21 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Pasta - rice daily
|
25 Participants
|
23 Participants
|
23 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Cereals - grains daily
|
28 Participants
|
29 Participants
|
27 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Nuts > 2 times per week
|
9 Participants
|
14 Participants
|
8 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Olive oil daily
|
29 Participants
|
28 Participants
|
29 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Skipping breakfast
|
7 Participants
|
6 Participants
|
9 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Dairy at breakfast
|
24 Participants
|
25 Participants
|
26 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Commercial pastries - pastries at breakfast
|
18 Participants
|
13 Participants
|
16 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
2 Yogurt - cheese servings daily
|
19 Participants
|
18 Participants
|
20 Participants
|
|
Mediterranean Diet Index (KIDMED) Analysis
Sweets and candies daily
|
23 Participants
|
17 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the baseline and 6 month time points.
antithyroid peroxidase antibody (Anti-TPOAb) titers
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Anti-TPOAb
6 months
|
800.00 IU/mL
Interval 73.47 to 1687.2
|
—
|
—
|
|
Anti-TPOAb
baseline
|
979.50 IU/mL
Interval 135.27 to 2383.72
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data have not been collected for the "Control Group" and "AIT Euthyroid Group" for the baseline and 6 month time points.
thyroglobulin antibody (Anti-TgAb) titers
Outcome measures
| Measure |
AIT Subclinical Hypothyroid Group
n=30 Participants
Children and Adolescents diagnosed with chronic autoimmune thyroiditis (AIT) and subclinical hypothyroidism (SCH) , receiving standard levothyroxine (LT4) treatment.
|
Control Group
Healthy individuals with no chronic autoimmune thyroiditis (AIT) and normal thyroid function (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
AIT Euthyroid Group
Children and Adolescents with chronic autoimmune thyroiditis and euthyroidism (age- and sex-matched with AIT Subclinical Hypothyroid Group).
|
|---|---|---|---|
|
Anti-TgAb
baseline
|
283.90 IU/mL
Interval 69.4 to 500.0
|
—
|
—
|
|
Anti-TgAb
6 months
|
236.20 IU/mL
Interval 87.95 to 500.0
|
—
|
—
|
Adverse Events
AIT Subclinical Hypothyroid Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AIT Euthyroid Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Assimina Galli-Tsinopoulou
2nd Department of Paediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA University Hospital, 54636 Thessaloniki,
Phone: +302310994802
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place