Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190214
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
Malaysian Endocrine and Metabolic Society
National University of Malaysia
University of Malaya
International Medical University
Information provided by (Responsible Party):
Dr Mohamnmad Arif Shahar, International Islamic University Malaysia

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
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.


Layout table for study information
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 : August 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016





Primary Outcome Measures :
  1. Number of participants with abnormal thyroid function [ Time Frame: Day 0 ]
    Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism


Secondary Outcome Measures :
  1. Number of participants with positive thyroid autoantibodies [ Time Frame: Day 0 ]
    Anti-thyroglobulin Anti-thyroperoxidase

  2. Number of participants with Iodine deficiency status [ Time Frame: Day 0 ]
    Urinary iodine level


Other Outcome Measures:
  1. 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)


Biospecimen Retention:   Samples With DNA
Whole Blood Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190214


Sponsors and Collaborators
International Islamic University Malaysia
Malaysian Endocrine and Metabolic Society
National University of Malaysia
University of Malaya
International Medical University
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Dr Mohamnmad Arif Shahar, Assist Prof, International Islamic University Malaysia
ClinicalTrials.gov Identifier: NCT02190214     History of Changes
Other Study ID Numbers: MyEndo-Thyroid
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by Dr Mohamnmad Arif Shahar, International Islamic University Malaysia:
Hyperthyroidism
Hypothyroidism
Autoimmune thyroid disorders
Iodine deficiency
Genetic susceptibility
Additional relevant MeSH terms:
Layout table for MeSH terms
Hashimoto Disease
Graves Disease
Thyroid Diseases
Hypothyroidism
Hyperthyroidism
Thyroiditis
Disease Susceptibility
Genetic Predisposition to Disease
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Autoimmune Diseases
Immune System Diseases
Thyroiditis, Autoimmune