Variations in the DIO2 and MCT10 Genes and Effect of Triiodothyronine Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Responders Patients in combination therapy due to persistent symptoms on L-thyroxin mono-therapy who experience a longtime effect of triiodothyronine treatment. |
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| Non-responders Patients who have tried combination therapy due to persistent symptoms on L-thyroxin mono-therapy, but did not experience a longtime effect. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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).
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Started in combination therapy with L-thyroxine and Liothyronine in an approximately 17/1 ratio
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Exclusion of an alternative explanation for persistent hypothyroid symptoms
Exclusion Criteria:
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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)
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Ongoing pregnancy
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Age below 18 years or above 80 years.
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Patients who do not read and understand information material given
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Patients who are not competent to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Hospital | Herlev | Denmark | 2730 |
Sponsors and Collaborators
- Birte Nygaard
Investigators
- Principal Investigator: Birte Nygaard, Ph.D., Herlev Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T3SNP