- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190214
Thyroid Disorders in Malaysia: A Nationwide Multicentre Study (MyEndo-Thyroid)
Thyroid Disorders in Malaysian: A Nationwide Multicentre Study
This will be a population based study looking at the prevalence of thyroid disorders in Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its association with different ethnicity and iodine status. The study will also look at genetic susceptibility for autoimmune thyroid disorders in the Malaysian population
General hypotheses:
The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population There are different susceptibility gene for autoimmune thyroid disorder in different ethnicity in our population
Study Overview
Status
Detailed Description
This will be a cross-sectional population based study involving Malaysian adults (aged 18 year old and above). Cluster sampling will be used to select respondents that will be representative of the Malaysian population. Selected respondent will be interviewed, anthropometric measurement taken, blood and urine sample taken.
Blood will be analyzed for thyroid function (thyroxine, triiodothyronine and thyroid stimulating hormone), autoantibodies (anti-thyroperoxidase and anti-thyroglobulin). Urine will be analyzed for urinary iodine.
Those diagnosed with autoimmune thyroid disorders with strong family history of thyroid disorders (multiplex multi-generation family involvement) will have their blood sent for whole exome sequencing and linkage analysis done to identify possible susceptible gene for autoimmune thyroid disorders
Respondents detected to have hypo- or hyper- and subclinical hypo- or hyperthyroidism will be referred to their nearest health centre for further evaluation and treatment appropriate for their condition.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged equal or more than 18 years old at the time of sampling
- Malaysian citizen
Exclusion Criteria:
- Respondents who did not give consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with abnormal thyroid function
Time Frame: Day 0
|
Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with positive thyroid autoantibodies
Time Frame: Day 0
|
Anti-thyroglobulin Anti-thyroperoxidase
|
Day 0
|
Number of participants with Iodine deficiency status
Time Frame: Day 0
|
Urinary iodine level
|
Day 0
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with genetic susceptibility to autoimmune thyroid disorders
Time Frame: Day 0
|
whole exome sequencing and linkage analysis in families with autoimmune thyroid disorders (multiplex multi-generation involvement)
|
Day 0
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nor Azmi Kamaruddin, MBBS, MMed, National University of Malaysia
- Principal Investigator: Norlela Sukor, MMed, Phd, National University of Malaysia
- Principal Investigator: Norhanita Othman, National University of Malaysia
- Principal Investigator: Johari Ali, University of Malaya
- Principal Investigator: Shirenee Vethakkan, University of Malaya
- Principal Investigator: Siew Kim Kwa, International Medical University
- Principal Investigator: Kuck Meng Chong, MD, Malaysian Endocrine and Metabolic Society
- Principal Investigator: Lecthuman Ramanathan, Malaysian Endocrine and Metabolic Society
- Principal Investigator: Hussein Zanariah, Malaysian Endocrine and Metabolic Society
- Principal Investigator: Nurain Mohd Noor, Malaysian Endocrine and Metabolic Society
- Principal Investigator: Norhaliza Mohd Ali, Malaysian Endocrine and Metabolic Society
- Principal Investigator: Norhayati Yahya, Malaysian Endocrine and Metabolic Society
- Principal Investigator: Nor Azizah Aziz, Malaysian Endocrine and Metabolic Society
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Endocrine System Diseases
- Disease Attributes
- Exophthalmos
- Orbital Diseases
- Goiter
- Thyroiditis, Autoimmune
- Hypothyroidism
- Thyroid Diseases
- Hyperthyroidism
- Disease Susceptibility
- Genetic Predisposition to Disease
- Hashimoto Disease
- Graves Disease
- Thyroiditis
Other Study ID Numbers
- MyEndo-Thyroid
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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