N/A
N=90
FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL)
Hashimoto Disease
Bottom Line
View on ClinicalTrials.gov: NCT02725879 ↗Enrolled (actual)
90
Serious AEs
—
Results posted
Feb 2024
Primary outcome: Primary: Fibroblast Growth Factor 21 (FGF-21) — 182.71; 217.36; 198.43 pg/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Aristotle University Of Thessaloniki
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibroblast Growth Factor 21 (FGF-21) |
182.71; 217.36; 198.43 | — |
| PRIMARY RMR/Weight/Day |
131.08; 150.46; 168.74; 142.51 | — |
| SECONDARY SDS BMI |
0.73; 0.88; 0.36; 0.88 | — |
| SECONDARY WAIST C. |
67.73; 69.33; 65.65; 69.2 | — |
| SECONDARY HIP C. |
81.38; 80.63; 77.41; 81.50 | — |
| SECONDARY MUAC |
22.00; 23.00; 21.00; 23.00 | — |
| SECONDARY %BF |
24.95; 22.6; 21.65; 24.06 | — |
| SECONDARY FMI |
4.49; 4.42; 4.12; 8.98 | — |
| SECONDARY FFMI |
14.27; 14.66; 13.47; 24.90 | — |
| SECONDARY TSH |
4.82; 2.40; 2.63; 4.03 | — |
| SECONDARY FT3 |
5.96; 6.28; 6.27; 5.90 | — |
| SECONDARY FT4 |
14.29; 15.19; 15.19; 15.70 | — |
| SECONDARY Glucose |
4.86; 4.88; 4.74; 4.97 | — |
| SECONDARY Insulin |
64.58; 48.12; 54.65; 65.07 | — |
| SECONDARY TC |
4.22; 3.88; 4.22; 4.19 | — |
| SECONDARY TG |
0.74; 0.52; 0.66; 0.73 | — |
| SECONDARY HDL |
1.43; 1.38; 1.54; 1.46 | — |
| SECONDARY LDL |
2.30; 2.07; 2.33; 2.30 | — |
| SECONDARY AST |
23.00; 24.50; 27.50; 22.00 | — |
| SECONDARY ALT |
15.00; 14.50; 16.50; 15.50 | — |
| SECONDARY γ-GT |
12.00; 12.00; 12.00; 11.00 | — |
| SECONDARY ALP |
200.00; 217; 217.00; 224.50 | — |
| SECONDARY Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) |
1.93; 1.50; 1.62; 1.90 | — |
| SECONDARY Mediterranean Diet Index (KIDMED) Score |
6.37; 5.77; 5.00 | — |
| SECONDARY Mediterranean Diet Index (KIDMED) Analysis |
16; 22; 20; 7; 13; 12 | — |
| SECONDARY Anti-TPOAb |
979.50; 800.00 | — |
| SECONDARY Anti-TgAb |
283.90; 236.20 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02725879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.