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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 June 2023 |
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Main ID: |
NCT03064542 |
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Date of registration:
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09/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Role of Thyroid Status in Regulating Brown Adipose Tissue Activity, White Adipose Tissue Partitioning and Resting Energy Expenditure
TRIBUTE |
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Scientific title:
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The Role of Thyroid Status in Regulating Brown Adipose Tissue Activity, White Adipose Tissue Partitioning and Resting Energy Expenditure |
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Date of first enrolment:
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October 13, 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03064542 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Singapore
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Age minimum:
21 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hyperthyroidism
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Intervention(s)
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Drug: carbimazole (CMZ) or thiamazole (TMZ)
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Primary Outcome(s)
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Thyroid function test (serum free thyroxine (FT4) and serum thyroid stimulating hormone (TSH).
[Time Frame: 6 months of treatment with an anti-thyroid drug]
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Secondary Outcome(s)
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Fat volume- White adipose tissue (WAT)
[Time Frame: 6 months of treatment with an anti-thyroid drug]
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Energy expenditure
[Time Frame: 6 months of treatment with an anti-thyroid drug]
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Fat volume- Brown adipose tissue (BAT)
[Time Frame: 6 months of treatment with an anti-thyroid drug]
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Body composition
[Time Frame: 6 months of treatment with an anti-thyroid drug]
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Infrared thermography (IRT)
[Time Frame: 6 months of treatment with an anti-thyroid drug]
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Secondary ID(s)
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2015/00718
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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