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

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ClinicalTrials.gov Identifier: NCT03926585
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Birte Nygaard, Herlev Hospital

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
Hypothyroidism

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Study Type : Observational
Estimated Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926585


Contacts
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Contact: Christian Z Jensen, MD 52652688 ext +45 christian.zinck.jensen.01@regionh.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Christian Z Jensen, MD    52652688 ext +45    christian.zinck.jensen.01@regionh.dk   
Sponsors and Collaborators
Birte Nygaard
Investigators
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Principal Investigator: Birte Nygaard, Ph.D. Herlev Hospital
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Responsible Party: Birte Nygaard, Chief Physician, Ph.D, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03926585    
Other Study ID Numbers: T3SNP
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases