HypothyroidismNCT03926585
Variations in the DIO2 and MCT10 Genes and Effect of Triiodothyronine Treatment
An observational study of Hypothyroidism, run by Birte Nygaard at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothyroidism
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2019to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
Secondary outcomes (8)
Proportion treated with triiodothyronine
How many patients are treated with triiodothyronine at least one year after initiation of combination therapy.
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
Quality of life questionnaire
Patients are scored on the ThyPRO questionnaire and a hypothyroid symptoms questionnaire.
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
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
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
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.
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
Have therapy changed after the patient left the department of endocrinology?
Current hypothyroidism treatment and doses of medication
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
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).
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
Osteoporosis
DXA-scan
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
Risk of arrhythmia
Puls and blood pressure is measured. If arrhythmia is suspected, an ECG is performed.
Measured: Single assessment point, from 1-10 years after initiation of combination therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start23 Apr 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birte Nygaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Birte Nygaard, Herlev Hospital
- Investigators
- Birte Nygaard, Ph.D., Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926585
- Sponsor's protocol ID
- T3SNP
- Status last verified
- May 2023
- First submitted
- 15 Apr 2019
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03926585
- Acronym / sponsor ID
- T3SNP
- Conditions
- Hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Birte NygaardUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Proportion treated with triiodothyronine
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Quality of life questionnaire
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Who controls the treatment?
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
How is current treatment controlled?
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
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
TSH
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Osteoporosis
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Risk of arrhythmia
Time frame: Single assessment point, from 1-10 years after initiation of combination therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birte Nygaard, Ph.D. principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Birte Nygaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymorphisms in DIO2/MCT10 and triiodothyronine treatment (time frame: Single assessment point, from 1-10 years after initiation of combination therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.