Thyroid Disorders in Malaysia: A Nationwide Multicentre Study

Hypothyroidism Clinical Trial

— MyEndo-Thyroid  

Official title:

Thyroid Disorders in Malaysian: A Nationwide Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190214
• Other study ID #: MyEndo-Thyroid
• Status: Completed
• Phase: N/A
• First received: July 9, 2014
• Last updated: October 17, 2016
• Start date: August 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: International Islamic University Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: National Medical Research Register
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2498
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Genetic Susceptibility
• Graves Disease
• Hashimoto Disease
• Hashimoto's Thyroiditis
• Hyperthyroidism
• Hypothyroidism
• Iodine Deficiency
• Subclinical Hyperthyroidism
• Subclinical Hypothyroidism
• Thyroid Diseases
• Thyroiditis

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
International Islamic University Malaysia	International Medical University, Malaysian Endocrine and Metabolic Society, National University of Malaysia, University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with genetic susceptibility to autoimmune thyroid disorders	whole exome sequencing and linkage analysis in families with autoimmune thyroid disorders (multiplex multi-generation involvement)	Day 0	No
Primary	Number of participants with abnormal thyroid function	Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism	Day 0	No
Secondary	Number of participants with positive thyroid autoantibodies	Anti-thyroglobulin Anti-thyroperoxidase	Day 0	No
Secondary	Number of participants with Iodine deficiency status	Urinary iodine level	Day 0	No