HypothyroidismNCT04098991
Improving White Matter Integrity With Thyroid Hormone
An observational study of Hypothyroidism, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Animal studies have shown that thyroid hormone can improve white matter integrity after damage to myelin, which insulates and protects nerves. It is currently unknown whether this type of repair can occur in humans. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxine
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 8 Nov 2019
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: We are seeking a population of subjects clinically indicated to receive thyroid hormone for hypothyroidism.
Who may be able to join
- Age: 21-60 years of age
- A diagnosis of primary hypothyroidism from autoimmune thyroiditis (Hashimoto)
- Able to give informed consent.
Who cannot join
- Major depressive disorder with or without active suicidal ideation
- Mild or major neurocognitive disorder;
- Presence of contraindications to magnetic resonance imaging (presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
- Inability to tolerate small, enclosed spaces without anxiety (e.g., claustrophobia)
- Unwilling/unable to sign informed consent document
- Positive urine drug screen results;
- Pregnancy (positive pregnancy test), trying to become pregnant, or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Animal studies have shown that thyroid hormone can improve white matter integrity after damage to myelin, which insulates and protects nerves. It is currently unknown whether this type of repair can occur in humans. The purpose of the proposed study is to examine the impact of thyroid hormone on white matter integrity in humans using two complementary, state-of-the-art neuroimaging techniques: high angular diffusion imaging and multicomponent relaxometry.
Read the detailed description
The ability to promote and support remyelination has wide-ranging implications for a number of neuropsychiatric conditions from multiple sclerosis to major depression. Pre-clinical evidence has demonstrated that thyroid hormone treatment, in the form of triiodothyronine (T3) or tetraiodothyronine (T4), can promote and support remyelination by increasing myelin basic protein mRNA and protein, oligodendrocyte proliferation and maturation, and fractional anisotropy (a diffusion imaging measure of white matter integrity). Pilot data from the investigator's studies suggest that baseline thyroid status is correlated with the integrity of white matter tracts associated with major depression. To date, the impact of thyroid hormone administration on white matter tracts has not been studied in vivo in adult humans. The purpose of the proposed pilot study is to examine changes in white matter tract integrity using high angular diffusion imaging and multi-component relaxometry in a population of subjects clinically indicated to receive thyroid hormone for hypothyroidism. The investigators will scan patients with hypothyroidism at the initiation of treatment and at three and six months after starting thyroid hormone treatment. The investigators will also administer scales assessing mood and cognition which have been shown to correlate with white matter integrity. The investigators hypothesize that thyroid hormone treatment will be associated with an increase in fractional anisotropy, a decrease in radial diffusivity, and an increase in the myelin water fraction (markers of improved myelination) that will correlate with improvements in cognition and mood ratings. If successful, this will be the first demonstration of improved white matter integrity with thyroid hormone replacement and pave the way for therapies designed to restore structural brain connectivity.
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxine
- Keywords
- neuroimaging, thyroid, white matter
- Medical subject headings
- Hypothyroidism, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
All participants will be treated for their hypothyroidism according to the standard of care as reflected in recent guidelines from the American Thyroid Association.
| Study group | Role | What they receive |
|---|---|---|
| Participants with primary hypothyroidism | All participants will receive the same treatment (levothyroxine, a synthetic T4 hormone replacement) at a dose that will be titrated using serum thyrotropin (TSH) levels as a goal, according to the American Thyroid Association Task Force recommendations Receives: Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Angular Diffusion Tensor Imaging
Change in baseline white matter track integrity at 3 months and 6 months
Measured: 6 months
Multi-Component Relaxometry
Change in baseline white matter track integrity at 3 months and 6 months
Measured: 6 months
Secondary outcomes (4)
Patient Health Questionaire
Self-report measure of depression severity, Items are summed (Not at all = 0; Several days = 1; More than half the days = 2; Nearly every day = 3), yielding a score from 0 to 27
Measured: Collected at Baseline, 3 month follow-up, 6 month follow-up
NIH Toolbox : Dimensional Change Card Sort Test
Behavioral measures of executive functioning
Measured: Collected at Baseline, 3 month follow-up, 6 month follow-up
NIH Toolbox : Pattern Comparison Processing Speed Test
Behavioral measures of processing-speed measure
Measured: Collected at Baseline, 3 month follow-up, 6 month follow-up
NIH Toolbox : Flanker Inhibitory Control and Attention Test
Behavioral measures of attention
Measured: Collected at Baseline, 3 month follow-up, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start8 Nov 2017
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
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
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Olusola Alade Ajilore, University of Illinois Chicago
- Investigators
- Olusola A Ajilore, MD/PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098991
- Sponsor's protocol ID
- 2016-0678
- Other IDs
- 5R21NS095723
- Status last verified
- Apr 2020
- First submitted
- 27 Feb 2018
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving White Matter Integrity With Thyroid Hormone
- ClinicalTrials.gov ID
- NCT04098991
- Acronym / sponsor ID
- 2016-0678
- Conditions
- Hypothyroidism
- Keywords
- neuroimaging, thyroid, white matter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 23 Sep 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.
Animal studies have shown that thyroid hormone can improve white matter integrity after damage to myelin, which insulates and protects nerves. It is currently unknown whether this type of repair can occur in humans. The purpose of the proposed study is to examine the impact of thyroid hormone on white matter integrity in humans using two complementary, state-of-the-art neuroimaging techniques: high angular diffusion imaging and multicomponent relaxometry.
Detailed description
The ability to promote and support remyelination has wide-ranging implications for a number of neuropsychiatric conditions from multiple sclerosis to major depression. Pre-clinical evidence has demonstrated that thyroid hormone treatment, in the form of triiodothyronine (T3) or tetraiodothyronine (T4), can promote and support remyelination by increasing myelin basic protein mRNA and protein, oligodendrocyte proliferation and maturation, and fractional anisotropy (a diffusion imaging measure of white matter integrity). Pilot data from the investigator's studies suggest that baseline thyroid status is correlated with the integrity of white matter tracts associated with major depression. To date, the impact of thyroid hormone administration on white matter tracts has not been studied in vivo in adult humans. The purpose of the proposed pilot study is to examine changes in white matter tract integrity using high angular diffusion imaging and multi-component relaxometry in a population of subjects clinically indicated to receive thyroid hormone for hypothyroidism. The investigators will scan patients with hypothyroidism at the initiation of treatment and at three and six months after starting thyroid hormone treatment. The investigators will also administer scales assessing mood and cognition which have been shown to correlate with white matter integrity. The investigators hypothesize that thyroid hormone treatment will be associated with an increase in fractional anisotropy, a decrease in radial diffusivity, and an increase in the myelin water fraction (markers of improved myelination) that will correlate with improvements in cognition and mood ratings. If successful, this will be the first demonstration of improved white matter integrity with thyroid hormone replacement and pave the way for therapies designed to restore structural brain connectivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with primary hypothyroidism | – | Drug: LevothyroxineAll participants will receive the same treatment (levothyroxine, a synthetic T4 hormone replacement) at a dose that will be titrated using serum thyrotropin (TSH) levels as a goal, according to the American Thyroid Association Task Force recommendations |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We are seeking a population of subjects clinically indicated to receive thyroid hormone for hypothyroidism.
Key inclusion criteria (3 listed)
- Age: 21-60 years of age
- A diagnosis of primary hypothyroidism from autoimmune thyroiditis (Hashimoto)
- Able to give informed consent.
Key exclusion criteria (7 listed)
- Major depressive disorder with or without active suicidal ideation
- Mild or major neurocognitive disorder;
- Presence of contraindications to magnetic resonance imaging (presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
- Inability to tolerate small, enclosed spaces without anxiety (e.g., claustrophobia)
- Unwilling/unable to sign informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineAll participants will be treated for their hypothyroidism according to the standard of care as reflected in recent guidelines from the American Thyroid Association. | Drug | Participants with primary hypothyroidism |
Primary outcome
High Angular Diffusion Tensor Imaging
Time frame: 6 months
Change in baseline white matter track integrity at 3 months and 6 months
Multi-Component Relaxometry
Time frame: 6 months
Change in baseline white matter track integrity at 3 months and 6 months
4 secondary outcomes
Patient Health Questionaire
Time frame: Collected at Baseline, 3 month follow-up, 6 month follow-up
NIH Toolbox : Dimensional Change Card Sort Test
Time frame: Collected at Baseline, 3 month follow-up, 6 month follow-up
NIH Toolbox : Pattern Comparison Processing Speed Test
Time frame: Collected at Baseline, 3 month follow-up, 6 month follow-up
NIH Toolbox : Flanker Inhibitory Control and Attention Test
Time frame: Collected at Baseline, 3 month follow-up, 6 month follow-up
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 10 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Olusola A Ajilore, MD/PhD principal investigator
University of Illinois Chicago
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 University of Illinois Chicago at 1 site in United States.
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 7 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 10 Apr 2020. 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 United States. 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?
High Angular Diffusion Tensor Imaging (time frame: 6 months). The study lists 2 primary outcomes in all. 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 10 Apr 2020.