Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02725879
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki

Brief Summary:
Thyroid hormone (TH) and fibroblast growth factor 21 (FGF-21) are reported to share common metabolic pathways and underlying mechanisms in terms of energy balance, thus affecting both thermogenesis and resting metabolic rate (RMR). Although FGF-21 levels has been studied in children and adolescents regarding obesity, body composition and insulin resistance, data in children and adolescents diagnosed with Hashimoto's thyroiditis are lacking. Therefore, the purpose of this study is to measure the RMR in children and adolescents diagnosed with clinical hypothyroidism due to thyroiditis Hashimoto just before starting levothyroxine treatment and after six months achieving an euthyroid state, and to detect any association between serum FGF-21 levels and RMR.

Condition or disease
Thyroiditis Hashimoto

Detailed Description:

Patients with hypothyroidism due to Hashimoto thyroiditis (HT) will receive standard treatment with levothyroxine by their attending physician in order to achieve an euthyroid status. Free T4 level is expected to be displayed within normal range (10-16 mg/dl) after the first few months of levothyroxine administration, and TSH level is expected to be less than 5mU / ml after 3-4 months. Participants will be re-examined in 6 months after the initiation of substitution pharmacotherapy with levothyroxine. Similarly, a control group consisted by healthy children and adolescents matched for age and gender will be re-examined after a 6- month interval from the initial measurements.

From all participants detailed medical history will be recorded and following parameters will be measured and calculated: Age and pubertal stage according Tanner, height, body weight, Body Mass Index (BMI),waist circumference, hip circumference, Mid Arm Circumference (MAC), skinfolds measurement (using a Harpenden skinfold caliper), in order to estimate the percentage (%) body fat. Measurement of RMR, with a portable device applying indirect calorimetry (Fitmate Cosmed, Italy) The blood samples will be collected and centrifuged immediately after the RMR measurement. Following parameters will be tested in serum: FGF-21 (measured by ELISA method), TSH, F-T3, F-T4, TPOAb, TgAb, Fasting Glucose, Insulin, TChol, TG, HDL, LDL, AST, ALT, γGT (applying automatic chemical analyzers and analogues reagents that already exist at the Hospital).

Additionally, a 3-day food dairy (two weekdays and one weekend day) will be completed by the participants and/or their caregivers just a week before the measurement of the RMR and the blood sampling.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Association of Serum Fibroblast Growth Factor 21 (FGF-21) Levels With Resting Metabolic Rate (RMR), in Children and Adolescents With Hashimoto's Thyroiditis.
Study Start Date : March 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Group/Cohort
HASIMOTO's PATIENTS (HT)
Children and Adolescents diagnosed with Hashimoto's clinical hypothyroidism.
CONTROL GROUP (C)
Healthy individuals matched for gender and age



Primary Outcome Measures :
  1. Measurement of FGF-21 serum levels in children and adolescents with Hashimoto's clinical hypothyroidism. [ Time Frame: 1year ]
    Measurement of FGF-21 serum levels before and after 6 month period with levothyroxine treatment in children and adolescents with Hashimoto's clinical hypothyroidism.


Secondary Outcome Measures :
  1. Measurement of RMR in children and adolescents with Hashimoto's clinical hypothyroidism. [ Time Frame: 1 year ]
    Measurement of RMR before and after 6 month period with levothyroxine treatment in children and adolescents with Hashimoto's clinical hypothyroidism.


Other Outcome Measures:
  1. Comparisons between initial and after 6 months levothyroxine treatment of FGF-21 serum levels and RMR. [ Time Frame: 1 year ]
    Comparison between the patient's group initial FGF-21 serum levels and RMR before and after levothyroxine treatment. Similar comparison will be done in the control group. Furthermore, a final comparison between patients and controls will be held.


Biospecimen Retention:   Samples Without DNA
Serum samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children and Adolescents of Greek origin who attend the Pediatric Endocrinology Outpatient Unit of 4th Department of Pediatrics,Medical School,Aristotle University of Thessaloniki for testing thyroid autoimmunity, as well as healthy controls.
Criteria

Inclusion Criteria:

For patients

  • Subjects 5 to 18 years old.
  • First diagnosis of hypothyroidism due to Hashimoto's thyroiditis (high levels of serum antithyroid autoantibodies (antiTPO, 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

  • Presence of euthyroidsm, subclinical hypothyroidism, hyperthyroidism.
  • Pre-existing medical treatment for clinical hypothyroidism.
  • 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 / hypo-cortisolemia, 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/ hypo-cortisolemia, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725879


Contacts
Layout table for location contacts
Contact: Assimina Galli-Tsinopoulou, MD,PhD 2310994801 ext +30 agalli@auth.gr

Locations
Layout table for location information
Greece
2nd Department of Paediatrics, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA Hospital Thessaloniki, Greece Recruiting
Thessaloniki, Greece, 546 21
Contact: Assimina Galli-Tsinopoulou, MD, PhD    +302310994801 ext +30    agalli@auth.gr   
Contact: Pavlos Drongitis, RD,MSc    302310994802 ext +30    droggpaul@yahoo.com   
Principal Investigator: Assimina Galli-Tsinopoulou, MD, PhD         
Sub-Investigator: Pavlos Drongitis, RD,MSc         
Sub-Investigator: Eleni Papaconstantinou, MD,PhD         
Sub-Investigator: Dalia Malkova, PhD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Layout table for investigator information
Principal Investigator: Assimina Galli-Tsinopoulou, MD,PhD 2nd Department of Paediatrics, AΗEPA Hospital

Publications:

Layout table for additonal information
Responsible Party: Assimina Galli-Tsinopoulou, Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02725879     History of Changes
Other Study ID Numbers: PEDIATRIC ENDOCRINOLOGY
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroiditis
Hashimoto Disease
Thyroid Diseases
Endocrine System Diseases
Thyroiditis, Autoimmune