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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responders | Patients in combination therapy due to persistent symptoms on L-thyroxin mono-therapy who experience a longtime effect of triiodothyronine treatment. | ||
| Non-responders | Patients who have tried combination therapy due to persistent symptoms on L-thyroxin mono-therapy, but did not experience a longtime effect. |
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| Measure | Description | Time Frame |
|---|---|---|
| Polymorphisms in DIO2/MCT10 and triiodothyronine treatment | 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 | Single assessment point, from 1-10 years after initiation of combination therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion treated with triiodothyronine | How many patients are treated with triiodothyronine at least one year after initiation of combination therapy. | Single assessment point, from 1-10 years after initiation of combination therapy |
| Quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in this study have been diagnosed with hypothyroidism and have had persistent hypothyroid symptoms despite L-thyroxine mono-therapy. They have all been referred to the department of endocrinology and have been examined by a trained endocrinologist. All patients have at least one year before the study initiated combination therapy with L-thyroxine and Liothyronine.
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| Name | Affiliation | Role |
|---|---|---|
| Birte Nygaard, Ph.D. | Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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Patients are scored on the ThyPRO questionnaire and a hypothyroid symptoms questionnaire. |
| Single assessment point, from 1-10 years after initiation of combination therapy |
| Who controls the treatment? | 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 | Single assessment point, from 1-10 years after initiation of combination therapy |
| How is current treatment controlled? | Patients report if current treatment is for example controlled by using blood samples or only on the basis of symptoms. | Single assessment point, from 1-10 years after initiation of combination therapy |
| Have therapy changed after the patient left the department of endocrinology? | Current hypothyroidism treatment and doses of medication | Single assessment point, from 1-10 years after initiation of combination therapy |
| TSH | 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). | Single assessment point, from 1-10 years after initiation of combination therapy |
| Osteoporosis | DXA-scan | Single assessment point, from 1-10 years after initiation of combination therapy |
| Risk of arrhythmia | Puls and blood pressure is measured. If arrhythmia is suspected, an ECG is performed. | Single assessment point, from 1-10 years after initiation of combination therapy |