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

NCT03926585 | Completed

• 1 other identifier: T3SNP
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Proportion treated with triiodothyronine

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

• Quality of life questionnaire

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

• Who controls the treatment?

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

• How is current treatment controlled?

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

• Have therapy changed after the patient left the department of endocrinology?

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Birte Nygaard: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Birte Nygaard, Ph.D.

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Ph.D

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 24, 2019
• Study Start: April 23, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

DK (1)