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

October 17, 2016 updated by: Dr Mohamnmad Arif Shahar, International Islamic University Malaysia

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

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

Observational

Enrollment (Actual)

2498

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult (aged equal or more than 18 years old ) Malaysian citizen living in Malaysia at the time of sampling

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (ESTIMATE)

July 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

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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