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

NCT ID: NCT03926585

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-23

Study Completion Date

2022-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Responders

Patients in combination therapy due to persistent symptoms on L-thyroxin mono-therapy who experience a longtime effect of triiodothyronine treatment.

No interventions assigned to this group

Non-responders

Patients who have tried combination therapy due to persistent symptoms on L-thyroxin mono-therapy, but did not experience a longtime effect.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Birte Nygaard

OTHER

Sponsor Role lead

Responsible Party

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Birte Nygaard

Chief Physician, Ph.D

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Birte Nygaard, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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T3SNP

Identifier Type: -

Identifier Source: org_study_id

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