Central HypothyroidismMATcHNCT03823859
Metabolomics of Thyroid Hormones
An observational study of Central Hypothyroidism and Hypothyroidism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to develop a metabolome signature of thyroid hormone status. The metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction diseases, especially in cases where TSH cannot be reliably used. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Hypothyroidism, Hypothyroidism, Hyperthyroidism
- What is being tested?
- Indirect calorimetry, Dual energy X-ray Absorptiometry (DXA) and Blood sampling
- How many people
- 332 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Dec 2018to 31 Dec 2021
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be recruited by means of advertisements (online or in the newspaper). Patients will be recruited from the endocrinology outpatient clinics of the Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel and patients referred from practicing endocrinologists.
Who may be able to join
- All participants:
- Age 18 to 80 years
- BMI 19 to 35 kg/m2
- Informed consent as documented by signature
- Patients with primary hyperthyroidism TSH < 0.2 mIU/l and free thyroxine (fT4) > 25 pM or fT3 > 8 pM
- Patients with primary hypothyroidism, currently not sufficiently substituted TSH > 8 milli-International unit (mIU)/l or fT4 < 10 pM
- Patients with diagnosis of primary hypothyroidism, sufficiently substituted Documented diagnosis of primary hypothyroidism Substitution with L-Thyroxin TSH in target range between 0.5 and 2.5 mIU/l
- Patients with secondary hypothyroidism Pituitary disease with documented secondary hypothyroidism
Who cannot join
- Diabetes mellitus (HbA1c >6.5%)
- Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
- Abuse of alcohol or illicit drugs
- Women who are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
About this study
The aim of this study is to develop a metabolome signature of thyroid hormone status. The metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction diseases, especially in cases where TSH cannot be reliably used.
Read the detailed description
Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not produce sufficient amounts of thyroid hormones. The substitution therapy is guided by measurement of the pituitary gland hormone thyrotropin (TSH). Patients with central hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to guide therapy. So far there are no reliable methods for therapy control in patients with central hypothyroidism.
The measurement of small endogenous metabolites might give investigators a metabolomics profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid state and therefore could be used for diagnosis and therapy control of thyroid dysfunction diseases.
- Conditions
- Central Hypothyroidism, Hypothyroidism, Hyperthyroidism
- Being tested
- Indirect calorimetry, Dual energy X-ray Absorptiometry (DXA), Blood sampling
- Keywords
- Hypothyroidism, Metabolomics, Thyroid Hormones, Hyperthyroidism
- Medical subject headings
- Hypothyroidism, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect calorimetryDiagnostic test
Resting energy expenditure
Dual energy X-ray Absorptiometry (DXA)Diagnostic test
Body composition
Blood samplingDiagnostic test
fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | * Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)
* Indirect calorimetry
* Dual energy X-ray Absorptiometry (DXA) Receives: Diagnostic Test: Indirect calorimetry; Diagnostic Test: Dual energy X-ray Absorptiometry (DXA); Diagnostic Test: Blood sampling | |
| Patients with thyroid dysfunction | Patients with Primary hypothyroidism newly diagnosed, Primary hypothyroidism substituted, hyperthyroidism, secondary hypothyroidism
* Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)
* Indirect calorimetry
* Dual energy X-ray Absorptiometry (DXA) Receives: Diagnostic Test: Indirect calorimetry; Diagnostic Test: Dual energy X-ray Absorptiometry (DXA); Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolome signature of thyroid Hormone Status (MSTH)
The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression.
Measured: baseline/single visit
Secondary outcomes (3)
Resting energy expenditure (REE)
Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry.
Measured: baseline/single visit
Body composition concerning muscle mass
Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA
Measured: baseline/single visit
Body composition concerning fat mass
Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA
Measured: baseline/single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start12 Dec 2018
- Primary completion28 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central HypothyroidismStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 332 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Matthias Betz, PD Dr. med., Study director, Klinik Endokrinologie, Diabetes und Metabolismus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823859
- Sponsor's protocol ID
- EKNZ 2018-01961
- Acronym
- MATcH
- Status last verified
- May 2022
- First submitted
- 28 Jan 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics of Thyroid Hormones
- ClinicalTrials.gov ID
- NCT03823859
- Acronym / sponsor ID
- MATcH / EKNZ 2018-01961
- Conditions
- Central Hypothyroidism, Hypothyroidism, Hyperthyroidism
- Keywords
- Hypothyroidism, Metabolomics, Thyroid Hormones, Hyperthyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Jan 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.
The aim of this study is to develop a metabolome signature of thyroid hormone status. The metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction diseases, especially in cases where TSH cannot be reliably used.
Detailed description
Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not produce sufficient amounts of thyroid hormones. The substitution therapy is guided by measurement of the pituitary gland hormone thyrotropin (TSH). Patients with central hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to guide therapy. So far there are no reliable methods for therapy control in patients with central hypothyroidism.
The measurement of small endogenous metabolites might give investigators a metabolomics profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid state and therefore could be used for diagnosis and therapy control of thyroid dysfunction diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: Indirect calorimetry, Diagnostic Test: Dual energy X-ray Absorptiometry (DXA), Diagnostic Test: Blood sampling* Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c) * Indirect calorimetry * Dual energy X-ray Absorptiometry (DXA) |
| Patients with thyroid dysfunction | – | Diagnostic Test: Indirect calorimetry, Diagnostic Test: Dual energy X-ray Absorptiometry (DXA), Diagnostic Test: Blood samplingPatients with Primary hypothyroidism newly diagnosed, Primary hypothyroidism substituted, hyperthyroidism, secondary hypothyroidism * Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c) * Indirect calorimetry * Dual energy X-ray Absorptiometry (DXA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be recruited by means of advertisements (online or in the newspaper). Patients will be recruited from the endocrinology outpatient clinics of the Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel and patients referred from practicing endocrinologists.
Key inclusion criteria (8 listed)
- Age 18 to 80 years
- BMI 19 to 35 kg/m2
- Informed consent as documented by signature
- Patients with primary hyperthyroidism TSH < 0.2 mIU/l and free thyroxine (fT4) > 25 pM or fT3 > 8 pM
- Patients with primary hypothyroidism, currently not sufficiently substituted TSH > 8 milli-International unit (mIU)/l or fT4 < 10 pM
Key exclusion criteria (6 listed)
- Diabetes mellitus (HbA1c >6.5%)
- Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
- Abuse of alcohol or illicit drugs
- Women who are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
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 |
|---|---|---|
| Indirect calorimetryResting energy expenditure | Diagnostic test | Healthy volunteers, Patients with thyroid dysfunction |
| Dual energy X-ray Absorptiometry (DXA)Body composition | Diagnostic test | Healthy volunteers, Patients with thyroid dysfunction |
| Blood samplingfT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel | Diagnostic test | Healthy volunteers, Patients with thyroid dysfunction |
Primary outcome
Metabolome signature of thyroid Hormone Status (MSTH)
Time frame: baseline/single visit
The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression.
3 secondary outcomes
Resting energy expenditure (REE)
Time frame: baseline/single visit
Body composition concerning muscle mass
Time frame: baseline/single visit
Body composition concerning fat mass
Time frame: baseline/single visit
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 17 May 2022.
Related trials for Central Hypothyroidism
RecruitingObservational study
Natural History of Sphingosine Phosphate Lyase Insufficiency Syndrome (SPLIS)
Sphingosine Phosphate Lyase Insufficiency Syndrome (SPLIS)
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Not yet recruitingObservational study
Ultrasound Measurement of Thyroid Volume in Term Newborns
Thyroid Volume, Thyroid Ultrasound
RecruitingObservational study
Role of Next Generation Sequencing in the Etiological Diagnosis of Permanent Congenital Hypothyroidism With in Situ Thyroid
Congenital Hypothyroidism
RecruitingObservational study
Improvement of Laboratory Diagnostics in Hypothyroid Patients Using Levothyroxine
Hypothyroidism
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.
Matthias Betz, PD Dr. med. study director
Klinik Endokrinologie, Diabetes und Metabolismus
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 Central Hypothyroidism and Hypothyroidism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 8 inclusion and 6 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 17 May 2022. 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 Switzerland. 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?
Metabolome signature of thyroid Hormone Status (MSTH) (time frame: baseline/single visit). 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 17 May 2022.