MyEndo-Thyroid: Thyroid Disorders in Malaysia: A Nationwide Multicentre Study

Sponsor

International Islamic University Malaysia (Other)

Overall Status

Completed

CT.gov ID

NCT02190214

Collaborator

Malaysian Endocrine and Metabolic Society (Other), National University of Malaysia (Other), University of Malaya (Other), International Medical University (Other)

2,498

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypothyroidism Subclinical Hypothyroidism Hyperthyroidism Subclinical Hyperthyroidism Graves Disease Hashimoto's Thyroiditis Iodine Deficiency Genetic Susceptibility

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 Design

Study Type:

Observational

Actual Enrollment :

2498 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

Official Title:

Thyroid Disorders in Malaysian: A Nationwide Multicentre Study

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Outcome Measures

Primary Outcome Measures

Number of participants with abnormal thyroid function [Day 0]
Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism

Secondary Outcome Measures

Number of participants with positive thyroid autoantibodies [Day 0]
Anti-thyroglobulin Anti-thyroperoxidase
Number of participants with Iodine deficiency status [Day 0]
Urinary iodine level

Other Outcome Measures

Number of participants with genetic susceptibility to autoimmune thyroid disorders [Day 0]
whole exome sequencing and linkage analysis in families with autoimmune thyroid disorders (multiplex multi-generation involvement)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

International Islamic University Malaysia
Malaysian Endocrine and Metabolic Society
National University of Malaysia
University of Malaya
International Medical University

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