An observational study in Hypothyroidism, sponsored by Birte Nygaard. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Birte Nygaard · Observational
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.
252 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.
This study's enrollment of 82 is below the median of 138 across 107 observational studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Birte Nygaard is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients in combination therapy due to persistent symptoms on L-thyroxin mono-therapy who experience a longtime effect of triiodothyronine treatment.
Patients who have tried combination therapy due to persistent symptoms on L-thyroxin mono-therapy, but did not experience a longtime effect.
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
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Proportion treated with triiodothyronine
How many patients are treated with triiodothyronine at least one year after initiation of combination therapy.
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Quality of life questionnaire
Patients are scored on the ThyPRO questionnaire and a hypothyroid symptoms questionnaire.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Osteoporosis
DXA-scan
Time frame: 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.
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in Aug 2022, 39 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Birte Nygaard