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Completed

NCT Number: NCT03926585

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

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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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Polymorphisms in DIO2/MCT10 and triiodothyronine treatment

    Time frame: 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 outcomes

  1. Proportion treated with triiodothyronine

    Time frame: 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.

  2. Quality of life questionnaire

    Time frame: Single assessment point, from 1-10 years after initiation of combination therapy

    Patients are scored on the ThyPRO questionnaire and a hypothyroid symptoms questionnaire.

  3. Who controls the treatment?

    Time frame: 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

  4. How is current treatment controlled?

    Time frame: 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.

  5. Have therapy changed after the patient left the department of endocrinology?

    Time frame: Single assessment point, from 1-10 years after initiation of combination therapy

    Current hypothyroidism treatment and doses of medication

  6. TSH

    Time frame: 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).

  7. Osteoporosis

    Time frame: Single assessment point, from 1-10 years after initiation of combination therapy

    DXA-scan

  8. Risk of arrhythmia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Birte Nygaard

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2019
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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