HypothyroidismHYMAQNCT02891668
Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
An observational study of Hypothyroidism, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This project has the following primary aims: The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxine treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to 20 May 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypothyroid patients.
Who may be able to join
- TSH > 10 mU/liter
Who cannot join
- Serious competing illness
- Pregnancy or planning to become pregnant
- Thyroidectomized patients
- Unable to speak and understand danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of internal Medicine, Herlev Hospital
Herlev, Capital Region, DK-2730
About this study
This project has the following primary aims:
The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment.
Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).
Read the detailed description
Subjects and Methods:
74 newly diagnosed hypothyroid patients of both genders and age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy. Participants will get an appointment immediately after diagnosis to avoid unnecessary delay of treatment. Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.
- Psychological test using:
- ThyPRO a thyroid-specific quality of life questionnaire(18),
- Cognitive function by CALCAP® Abbreviated Test Battery,
- Perceived cognitive deficit questionnaire (Perceived Deficits Questionaire)
- Major Depression Inventory (MDI) questionnaire
- REE will be measured by a CCM-express calorimeter,
- DEXA-scan
- Blood samples will be taken and patients will be characterized through basic information.
- Insulin resistance will be assess through an oral glucose tolerance test (OGTT) At end of the first experimental day patients will start L-T4 therapy following national guidelines, with regular control of thyroid hormones to ensure optimal treatment. When patients are euthyroid and TSH is below 4 * 10-3 International Units pr liter (mU/l) patients will have blood samples monitored every 3 months for the rest of the trial.
After 6 and 12 months of treatment patients will undergo a similar experimental day and return to their general practitioner or outpatient clinic.
A control group of 18 matched healthy persons will undergo the first experimental day in the same way as the hypothyroid patients, except they do not start any kind of therapy and they only participate in the first experimental day.
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxine treatment
- Keywords
- Basal Metabolic rate, Quality of life, Resting energy expenditure, Insulin resistance, Cognitive Function, Body Composition
- Medical subject headings
- Hypothyroidism, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine treatmentDrug
Also called Eltroxin, Euthyrox
Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.
| Study group | Role | What they receive |
|---|---|---|
| Hypothyroid | Levothyroxine treatment Receives: Drug: Levothyroxine treatment | |
| Healthy volunteers | Matched on age and BMI 18 persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life as measured with the ThyPro questionaire
Measured: 1 year
Changes in resting energy expenditure in KCal/day
Measured: 1 year
Secondary outcomes (10)
Changes in Perceived Deficit Questionaire
Measured: 1 year
Changes in insulin resistance evaluated by MATSUDA index
Measured: 1 year
Changes in insulin resistance evaluated by HOMA index
Measured: 1 year
Changes in cognitive tests
Measured: 1 year
Changes in body composition asses through lean mass
Measured: 1 year
Changes in body composition asses through visceral adipose tissue
Measured: 1 year
Changes in body composition asses through fat mass
Measured: 1 year
Changes in free fatty acids
Measured: 1 year
Changes in cholesterol
Measured: 1 year
Changes in serum triglycerides
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMay 2015
- Primary completion20 May 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjarke Borregaard Medici, Herlev Hospital
- Investigators
- Bjarke Medici, MD, Principal investigator, Bjarke Medici
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891668
- Sponsor's protocol ID
- Herlev-Hymaq
- Acronym
- HYMAQ
- Status last verified
- Jul 2018
- First submitted
- 17 May 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Medici BB, Lerche la Cour J, Knop FK, Krakauer M, Michaelsson LF, Faber J, Watt T, Nygaard B. Predictors of Improvement in Quality of Life When Treating Hypothyroidism. J Thyroid Res. 2021 Jun 11;2021:5577217. doi: 10.1155/2021/5577217. eCollection 2021.
PubMed 34194721
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
- ClinicalTrials.gov ID
- NCT02891668
- Acronym / sponsor ID
- HYMAQ / Herlev-Hymaq
- Conditions
- Hypothyroidism
- Keywords
- Basal Metabolic rate, Quality of life, Resting energy expenditure, Insulin resistance, Cognitive Function, Body Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
This project has the following primary aims:
The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment.
Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).
Detailed description
Subjects and Methods:
74 newly diagnosed hypothyroid patients of both genders and age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy. Participants will get an appointment immediately after diagnosis to avoid unnecessary delay of treatment. Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.
- Psychological test using:
- ThyPRO a thyroid-specific quality of life questionnaire(18),
- Cognitive function by CALCAP® Abbreviated Test Battery,
- Perceived cognitive deficit questionnaire (Perceived Deficits Questionaire)
- Major Depression Inventory (MDI) questionnaire
- REE will be measured by a CCM-express calorimeter,
- DEXA-scan
- Blood samples will be taken and patients will be characterized through basic information.
- Insulin resistance will be assess through an oral glucose tolerance test (OGTT) At end of the first experimental day patients will start L-T4 therapy following national guidelines, with regular control of thyroid hormones to ensure optimal treatment. When patients are euthyroid and TSH is below 4 * 10-3 International Units pr liter (mU/l) patients will have blood samples monitored every 3 months for the rest of the trial.
After 6 and 12 months of treatment patients will undergo a similar experimental day and return to their general practitioner or outpatient clinic.
A control group of 18 matched healthy persons will undergo the first experimental day in the same way as the hypothyroid patients, except they do not start any kind of therapy and they only participate in the first experimental day.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothyroid | – | Drug: Levothyroxine treatmentLevothyroxine treatment |
| Healthy volunteers | – | –Matched on age and BMI 18 persons |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypothyroid patients.
Key inclusion criteria (1 listed)
- TSH > 10 mU/liter
Key exclusion criteria (4 listed)
- Serious competing illness
- Pregnancy or planning to become pregnant
- Thyroidectomized patients
- Unable to speak and understand danish
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 |
|---|---|---|
| Levothyroxine treatmentAlso: Eltroxin, EuthyroxEltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not. | Drug | Hypothyroid |
Primary outcome
Changes in quality of life as measured with the ThyPro questionaire
Time frame: 1 year
Changes in resting energy expenditure in KCal/day
Time frame: 1 year
10 secondary outcomes
Changes in Perceived Deficit Questionaire
Time frame: 1 year
Changes in insulin resistance evaluated by MATSUDA index
Time frame: 1 year
Changes in insulin resistance evaluated by HOMA index
Time frame: 1 year
Changes in cognitive tests
Time frame: 1 year
Changes in body composition asses through lean mass
Time frame: 1 year
Changes in body composition asses through visceral adipose tissue
Time frame: 1 year
Changes in body composition asses through fat mass
Time frame: 1 year
Changes in free fatty acids
Time frame: 1 year
Changes in cholesterol
Time frame: 1 year
Changes in serum triglycerides
Time frame: 1 year
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 1 Aug 2018.
- Derived from this study: PubMed 34194721Medici BB, Lerche la Cour J, Knop FK, Krakauer M, Michaelsson LF, Faber J, Watt T, Nygaard B. Predictors of Improvement in Quality of Life When Treating Hypothyroidism. J Thyroid Res. 2021 Jun 11;2021:5577217. doi: 10.1155/2021/5577217. eCollection 2021.
- 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.
Bjarke Medici, MD principal investigator
Bjarke Medici
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 Herlev Hospital 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 1 inclusion and 4 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 1 Aug 2018. 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?
Changes in quality of life as measured with the ThyPro questionaire (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT02891668, which also lists 1 linked publication.
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 1 Aug 2018.