Variations in the DIO2 and MCT10 Genes and Effect of Triiodothyronine Treatment
- Conditions
- Hypothyroidism
- Registration Number
- NCT03926585
- Lead Sponsor
- Birte Nygaard
- Brief Summary
Hypothesis: Variations in the deiodinase 2 gene and monocarboxylate transporter 10 gene is associated with improvement in quality of life after initiation of combination therapy with L-Thyroxine and Liothyronine in patients with persistent hypothyroid symptoms despite conventional L-thyroxine mono-therapy.
Purpose: To re-test this hypothesis in patients with continued perceived effect of Liothyronine treatment at least one year after initiation in a patient population more representing of daily clinical practice. The study will help determine whether testing of specific gene variations might predict longtime effect of combination therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- Patients admitted to the department of endocrinology with the diagnose hypothyroidism because of persistent hypothyroid symptoms despite treatment with L-thyroxine mono-therapy and normal and stable TSH (for at least 6 months).
- Started in combination therapy with L-thyroxine and Liothyronine in an approximately 17/1 ratio
- Exclusion of an alternative explanation for persistent hypothyroid symptoms
- Initiation of L-thyroxine treatment in patients with s-TSH below upper normal limit (with assay in current use, that is TSH < 4 mU/L)
- Ongoing pregnancy
- Age below 18 years or above 80 years.
- Patients who do not read and understand information material given
- Patients who are not competent to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Polymorphisms in DIO2/MCT10 and triiodothyronine treatment Single assessment point, from 1-10 years after initiation of combination therapy Group 1(responders) and group 2(non-responders) are compared with regard to polymorphisms in the DIO2 gene and the MCT10 gene. Polymorphisms will be determined from DNA in a blood sample
- Secondary Outcome Measures
Name Time Method Who controls the treatment? Single assessment point, from 1-10 years after initiation of combination therapy Patients report whether treatment is controlled by 1) a general practitioner 2) Patient self 3) other type of healthcare professional 4) a certified endocrinologist or 5) other
Risk of arrhythmia Single assessment point, from 1-10 years after initiation of combination therapy Puls and blood pressure is measured. If arrhythmia is suspected, an ECG is performed.
Quality of life questionnaire Single assessment point, from 1-10 years after initiation of combination therapy Patients are scored on the ThyPRO questionnaire and a hypothyroid symptoms questionnaire.
Osteoporosis Single assessment point, from 1-10 years after initiation of combination therapy DXA-scan
Proportion treated with triiodothyronine Single assessment point, from 1-10 years after initiation of combination therapy How many patients are treated with triiodothyronine at least one year after initiation of combination therapy.
How is current treatment controlled? Single assessment point, from 1-10 years after initiation of combination therapy Patients report if current treatment is for example controlled by using blood samples or only on the basis of symptoms.
Have therapy changed after the patient left the department of endocrinology? Single assessment point, from 1-10 years after initiation of combination therapy Current hypothyroidism treatment and doses of medication
TSH Single assessment point, from 1-10 years after initiation of combination therapy Is the patient well regulated? Normal TSH: 0.1-4.0 (depending on assay used). Over-treatment: TSH \< 0.1 (depending on assay used). Under-treatment: TSH\>4 (depending on assay used).
Trial Locations
- Locations (1)
Herlev Hospital
🇩🇰Herlev, Denmark