Hypothyroidism
Conditions
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.
Interventions
None listed
Sponsors
Birte Nygaard
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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). |
| Osteoporosis | Single assessment point, from 1-10 years after initiation of combination therapy | DXA-scan |
| 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. |
| 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 |
Countries
Denmark
Outcome results
None listed