Subclinical Hypothyroidisms
Conditions
Brief summary
The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)
Detailed description
In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.
Interventions
Levothyroxine Sodium(50ug/Tablets,dosage form 25ug,once a day) was administered to patients with autoimmune thyroiditis with mild subclinical hypothyroidism,
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men or women between the ages of 18 and 75; * Diagnostic criteria for mild subclinical hypothyroidism :TSH\>10mIU/L, thyroxine and free thyroxine levels were normal * Positive thyroglobulin antibody and/or Thyroperoxidase antibody * No previous use of drugs affecting thyroid function
Exclusion criteria
* The contraindications indicated in the Chinese instructions of the drug * Liver function impairment * Renal function impairment * Claustrophobia * Mental disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thyroid Stimulating Hormone changes | Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up | Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up |
| free thyroxine changes | free thyroxine changes from baseline and 12 weeks during follow-up | free thyroxine changes from baseline and 12 weeks during follow-up |
| T1-mapping values of Thyroid MRI | T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up | T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up |
| Free triiodothyronine changes | Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up | Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti-thyroid peroxidase antibody changes | anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up | anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up |
| anti-thyroglobulin antibody changes | anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up | anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up |
Countries
China
Contacts
Primary ContactJia Liu, MD
Backup ContactXiaomeng Sun, MD
Outcome results
None listed