Variations in the DIO2 and MCT10 Genes and Effect of Triiodothyronine Treatment

Hypothyroidism Clinical Trial

Official title:

Longtime Effect of Combination Treatment With L-thyroxine (L-T4) and Liothyronine (L-T3) in Patients With Persistent Hypothyroid Symptoms - Relation to Polymorphisms (SNP) in the DIO2 and the MCT10 Gene

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926585
• Other study ID #: T3SNP
• Status: Completed
• Start date: April 23, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2023
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Birte Nygaard

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Quality of life questionnaire	Patients are scored on the ThyPRO questionnaire and a hypothyroid symptoms questionnaire.	Single assessment point, from 1-10 years after initiation of combination therapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Osteoporosis	DXA-scan	Single assessment point, from 1-10 years after initiation of combination therapy
Secondary	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