HyperthyroidismTRIBUTENCT03064542
The Role of Thyroid Status in Regulating Brown Adipose Tissue Activity, White Adipose Tissue Partitioning and Resting Energy Expenditure
An observational study of Hyperthyroidism, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
To determine how thyroid status regulates the relationship between brown adipose tissue (BAT) volume/activity, white adipose tissue (WAT) partitioning and basal metabolic rate (BMR) in hyperthyroid patients transitioning to euthyroidism via antithyroid drugs. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- carbimazole (CMZ) or thiamazole (TMZ)
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Oct 2015to 19 May 2023
- How long will I take part?
- 6 Months
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Hyperthyroid patients diagnosed with Graves' disease
Who may be able to join
- You must be aged 21 to 50 years old (no gender restrictions).
- You must be diagnosed with Graves' disease.
- You are able to give informed consent..
- You must have body mass index (BMI) between 18.5 to 29.9 kg/m2 inclusive.
- You must be treated with carbimazole (CMZ) or thiamazole (TMZ) and compliant to treatment.
- Willing to avail yourself for the whole study and follow study procedures.
Who cannot join
- Chronic illnesses such as diabetes mellitus or cancer.
- You have a known history of liver or kidney disease.
- Female subjects who are pregnant or contemplating pregnancy.
- Those allergic to carbimazole (CMZ) or thiamazole (TMZ).
- History of surgery with metallic clips, staples or stents.
- Those on drugs that might affect body composition (eg. steroids) or BAT (eg. beta-blockers).
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- Those with poor compliance to medication.
- Presence of cardiac pacemaker or other foreign body in any part of the body.
- History of claustrophobia particularly in a MRI scanner.
- Those with a history of bronchial asthma.
- Those with overt congestive heart failure.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Tan Tock Seng Hospital, Endocrinology Clinic
Singapore, 308433
About this study
To determine how thyroid status regulates the relationship between brown adipose tissue (BAT) volume/activity, white adipose tissue (WAT) partitioning and basal metabolic rate (BMR) in hyperthyroid patients transitioning to euthyroidism via antithyroid drugs.
To compare euthyroid outcomes (BAT, WAT, BMR, body composition, body weight and insulin resistance) achieved by hypothalamus-pituitary-thyroid (HPT) set point vs. normal ranges of plasma free thyroxine 4 (FT4) and throxine stimulating hormone (TSH).
Read the detailed description
Study Visit 1 is meant to confirm if subject's hyperthyroidism is due to Graves' disease via a blood test called TSH receptor autoantibody (TRAb). This is a standard test that the doctor will routinely order as part of clinical practice to diagnose the cause of the subject's hyperthyroidism and is not part of the research procedure. If this TRAb blood test has been done before the subjects have been referred to the endocrinology clinic at TTSH, the doctors will review that result and decide if a repeat test is needed. If subjects are confirmed by blood tests to have Graves' disease type of hyperthyroidism, they are eligible to take part in this study. However, approximately 2 teaspoons (~ 10 mL) of blood will be taken for baseline thyroid function test just prior to the initiation of anti-thyroid drugs. Pre-menopausal women will also undergo a urine pregnancy test to exclude pregnancy prior to participation at study entry. Once subjects have consented to participate in this study, they will receive standard antithyroid drug (ATD) therapy as indicated clinically which in current practice will either be carbimazole (CMZ) or thiamazole (TMZ).The clinic endocrinologists at TTSH will be in charge of deciding on the ATD dose required based on the latest FT4, FT3 and TSH blood test results as per standard medical practice. . Subjects will then be scheduled for Visit 2 for baseline research measurements while you are still hyperthyroid.
On Study Visit 2, subjects will be asked to come to the Clinical Nutrition Research Centre (CNRC) at the Centre for Translational Medicine at the National University of Singapore in the morning at 0830 h after an overnight fast of 8-10 hours. Subjects will undergo anthropometry (ie. measures of body weight, height, waist and hip circumference), non-invasive percentage fat estimation using bioelectrical impedence analysis (BIA) and body composition evaluation using dual energy X-ray absorptiometry (DXA) which allows quantification of fat, lean and bone mass. Subjects will then undergo metabolic rate measurement in a whole body calorimeter coupled with infrared thermography using a thermal camera mounted on a tripod stand (IRT) focusing on the neck and area above the collar bone in a whole body room calorimeter for the next 45 minutes.
Subjects will then proceed to the Clinical Imaging Research Centre (CIRC) also located in the same building at the basement where an intravenous indwelling cannula will be inserted into an arm vein from which a fasting blood sample will be taken. At first, 30 mL of blood will be taken (about 6 teaspoons) in which 10 mL will be tested for thyroid function while the other 10 mL will be tested for liver and kidney function and the remaining 10mL for fasting glucose, insulin and lipids. An additional 20 mL blood (about 4 teaspoons) will be taken for analysis of markers of fat metabolism and protein profiles reflective of brown fat activity. A urine sample will also be collected. Subsequently, subjects will be given an intravenous injection of a radioactive labeled glucose called 18-FDG through the intravenous cannula and followed by PET and fat fraction MRI scanning for BAT and MRI-MRS of abdominal white fat for the next 1 hour.
After that, subjects will then be required to go to the endocrinology clinic at TTSH for control of their hyperthyroidism via ATD. This may take about 6 months to attain stable thyroid hormones levels (FT4, FT3, TSH). Subjects will be followed up every 6-8 weeks as per standard medical practice by theTTSH endocrinologist and have their ATD doses adjusted till their thyroid function tests are stable'. When this happens, subjects will continue with the remaining part of the research, which is Study Visit 3. With the exception an additional urine pregnancy test, Study Visit 3 is exactly the same as Study Visit 2.
- Conditions
- Hyperthyroidism
- Being tested
- carbimazole (CMZ) or thiamazole (TMZ)
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbimazole (CMZ) or thiamazole (TMZ)Drug
CMZ or TMZ will be used to treat the hyperthyroidism till the FT4/TSH is in normal range.
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid function test (serum free thyroxine (FT4) and serum thyroid stimulating hormone (TSH).
This observation supports the concept of a unique set point in FT4 and TSH for any given individual and forms the basis for optimization of thyroid status by targeting the FT4 and TSH levels towards the set point. All data, study and clinical endpoints will be analyzed and correlated by the proximity of the final stable euthyroid Thyroid function test (TFT) to the predicted euthyroid set point using the computer software.
Measured: 6 months of treatment with an anti-thyroid drug
Secondary outcomes (5)
Fat volume- Brown adipose tissue (BAT)
The above volumes will be measured at start of treatment and at 6 months by MRI (fat fraction for BAT) - volumes in mL.
Measured: 6 months of treatment with an anti-thyroid drug
Fat volume- White adipose tissue (WAT)
The above volumes will be measured at start of treatment and at 6 months by MRI (standard MRI for WAT) - volumes in mL.
Measured: 6 months of treatment with an anti-thyroid drug
Energy expenditure
The metabolic rate (measured from the energy expenditure) will be measured using the whole body calorimeter in kcal/day.
Measured: 6 months of treatment with an anti-thyroid drug
Body composition
The subjects will have a body composition evaluated by DXA at the start of treatment and 6 months post-treatment when they are rendered euthyroid. WE will measure lean mass, fat mass and bone mass.
Measured: 6 months of treatment with an anti-thyroid drug
Infrared thermography (IRT)
We will measure BAT activity using IRT. This will be expressed in terms of temperature change in degrees Celsius and heat power change in watts (W).
Measured: 6 months of treatment with an anti-thyroid drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start13 Oct 2015
- Primary completion19 May 2023
- Study completion19 May 2023
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 HyperthyroidismStudies 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
- Other
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Principal investigator, Melvin Leow, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064542
- Sponsor's protocol ID
- 2015/00718
- Other IDs
- 2015
- Acronym
- TRIBUTE
- Status last verified
- May 2023
- First submitted
- 9 Feb 2017
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun L, Goh HJ, Verma S, Govindharajulu P, Sadananthan SA, Michael N, Henry CJ, Goh JP, Velan SS, Leow MK. Brown adipose tissues mediate the metabolism of branched chain amino acids during the transitioning from hyperthyroidism to euthyroidism (TRIBUTE). Sci Rep. 2022 Mar 7;12(1):3693. doi: 10.1038/s41598-022-07701-7.
PubMed 35256693
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
- The Role of Thyroid Status in Regulating Brown Adipose Tissue Activity, White Adipose Tissue Partitioning and Resting Energy Expenditure
- ClinicalTrials.gov ID
- NCT03064542
- Acronym / sponsor ID
- TRIBUTE / 2015/00718
- Conditions
- Hyperthyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Agency for Science, Technology and Research
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 27 Feb 2017 (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.
To determine how thyroid status regulates the relationship between brown adipose tissue (BAT) volume/activity, white adipose tissue (WAT) partitioning and basal metabolic rate (BMR) in hyperthyroid patients transitioning to euthyroidism via antithyroid drugs.
To compare euthyroid outcomes (BAT, WAT, BMR, body composition, body weight and insulin resistance) achieved by hypothalamus-pituitary-thyroid (HPT) set point vs. normal ranges of plasma free thyroxine 4 (FT4) and throxine stimulating hormone (TSH).
Detailed description
Study Visit 1 is meant to confirm if subject's hyperthyroidism is due to Graves' disease via a blood test called TSH receptor autoantibody (TRAb). This is a standard test that the doctor will routinely order as part of clinical practice to diagnose the cause of the subject's hyperthyroidism and is not part of the research procedure. If this TRAb blood test has been done before the subjects have been referred to the endocrinology clinic at TTSH, the doctors will review that result and decide if a repeat test is needed. If subjects are confirmed by blood tests to have Graves' disease type of hyperthyroidism, they are eligible to take part in this study. However, approximately 2 teaspoons (~ 10 mL) of blood will be taken for baseline thyroid function test just prior to the initiation of anti-thyroid drugs. Pre-menopausal women will also undergo a urine pregnancy test to exclude pregnancy prior to participation at study entry. Once subjects have consented to participate in this study, they will receive standard antithyroid drug (ATD) therapy as indicated clinically which in current practice will either be carbimazole (CMZ) or thiamazole (TMZ).The clinic endocrinologists at TTSH will be in charge of deciding on the ATD dose required based on the latest FT4, FT3 and TSH blood test results as per standard medical practice. . Subjects will then be scheduled for Visit 2 for baseline research measurements while you are still hyperthyroid.
On Study Visit 2, subjects will be asked to come to the Clinical Nutrition Research Centre (CNRC) at the Centre for Translational Medicine at the National University of Singapore in the morning at 0830 h after an overnight fast of 8-10 hours. Subjects will undergo anthropometry (ie. measures of body weight, height, waist and hip circumference), non-invasive percentage fat estimation using bioelectrical impedence analysis (BIA) and body composition evaluation using dual energy X-ray absorptiometry (DXA) which allows quantification of fat, lean and bone mass. Subjects will then undergo metabolic rate measurement in a whole body calorimeter coupled with infrared thermography using a thermal camera mounted on a tripod stand (IRT) focusing on the neck and area above the collar bone in a whole body room calorimeter for the next 45 minutes.
Subjects will then proceed to the Clinical Imaging Research Centre (CIRC) also located in the same building at the basement where an intravenous indwelling cannula will be inserted into an arm vein from which a fasting blood sample will be taken. At first, 30 mL of blood will be taken (about 6 teaspoons) in which 10 mL will be tested for thyroid function while the other 10 mL will be tested for liver and kidney function and the remaining 10mL for fasting glucose, insulin and lipids. An additional 20 mL blood (about 4 teaspoons) will be taken for analysis of markers of fat metabolism and protein profiles reflective of brown fat activity. A urine sample will also be collected. Subsequently, subjects will be given an intravenous injection of a radioactive labeled glucose called 18-FDG through the intravenous cannula and followed by PET and fat fraction MRI scanning for BAT and MRI-MRS of abdominal white fat for the next 1 hour.
After that, subjects will then be required to go to the endocrinology clinic at TTSH for control of their hyperthyroidism via ATD. This may take about 6 months to attain stable thyroid hormones levels (FT4, FT3, TSH). Subjects will be followed up every 6-8 weeks as per standard medical practice by theTTSH endocrinologist and have their ATD doses adjusted till their thyroid function tests are stable'. When this happens, subjects will continue with the remaining part of the research, which is Study Visit 3. With the exception an additional urine pregnancy test, Study Visit 3 is exactly the same as Study Visit 2.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hyperthyroid patients diagnosed with Graves' disease
Key inclusion criteria (6 listed)
- You must be aged 21 to 50 years old (no gender restrictions).
- You must be diagnosed with Graves' disease.
- You are able to give informed consent..
- You must have body mass index (BMI) between 18.5 to 29.9 kg/m2 inclusive.
- You must be treated with carbimazole (CMZ) or thiamazole (TMZ) and compliant to treatment.
Key exclusion criteria (11 listed)
- Chronic illnesses such as diabetes mellitus or cancer.
- You have a known history of liver or kidney disease.
- Female subjects who are pregnant or contemplating pregnancy.
- Those allergic to carbimazole (CMZ) or thiamazole (TMZ).
- History of surgery with metallic clips, staples or stents.
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 |
|---|---|---|
| carbimazole (CMZ) or thiamazole (TMZ)CMZ or TMZ will be used to treat the hyperthyroidism till the FT4/TSH is in normal range. | Drug | – |
Primary outcome
Thyroid function test (serum free thyroxine (FT4) and serum thyroid stimulating hormone (TSH).
Time frame: 6 months of treatment with an anti-thyroid drug
This observation supports the concept of a unique set point in FT4 and TSH for any given individual and forms the basis for optimization of thyroid status by targeting the FT4 and TSH levels towards the set point. All data, study and clinical endpoints will be analyzed and correlated by the proximity of the final stable euthyroid Thyroid function test (TFT) to the predicted euthyroid set point using the computer software.
5 secondary outcomes
Fat volume- Brown adipose tissue (BAT)
Time frame: 6 months of treatment with an anti-thyroid drug
Fat volume- White adipose tissue (WAT)
Time frame: 6 months of treatment with an anti-thyroid drug
Energy expenditure
Time frame: 6 months of treatment with an anti-thyroid drug
Body composition
Time frame: 6 months of treatment with an anti-thyroid drug
Infrared thermography (IRT)
Time frame: 6 months of treatment with an anti-thyroid drug
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.
- Derived from this study: PubMed 35256693Sun L, Goh HJ, Verma S, Govindharajulu P, Sadananthan SA, Michael N, Henry CJ, Goh JP, Velan SS, Leow MK. Brown adipose tissues mediate the metabolism of branched chain amino acids during the transitioning from hyperthyroidism to euthyroidism (TRIBUTE). Sci Rep. 2022 Mar 7;12(1):3693. doi: 10.1038/s41598-022-07701-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyperthyroidism, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 6 inclusion and 11 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 Singapore. 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?
Thyroid function test (serum free thyroxine (FT4) and serum thyroid stimulating hormone (TSH). (time frame: 6 months of treatment with an anti-thyroid drug). 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 NCT03064542, 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 25 May 2023.