Large cohort study on diabetes launched

The Seremban Diabetes (SeDia) Cohort Study, the first large-scale diabetes study of its kind in Malaysia has been launched by the Ministry of Health Malaysia (MOH) and International Medical University (IMU). The 12-year study marks the first important step towards obtaining data that is socioculturally relevant to the local community.

The study’s key objective is to holistically explore all the factors involved in the development of diabetes and complications experienced by patients. It involves over 5,000 patients registered as part of the Klinik Kesihatan Seremban’s Diabetes Registry and over 7,000 of their family members, to investigate the complex web of interactions that contribute to the development of diabetes and its complications. A significant amount of time will be required in this study because the development of diabetes, along with its associated complications, also occur over an extended period.

The SeDia Cohort Study will cover a comprehensive examination of various factors ranging from genetics and family history of diabetes to lifestyle and environmental factors, dietary regimes, physical activity, socioeconomic levels, and healthcare delivery. Understanding the complex connections between these factors is hoped to result in optimal strategies for diabetes prevention and treatment. Subsequently, this knowledge can be translated into implementing evidence-based public healthcare policies and programmes that are relevant to the local community. This ensures the efficacy of developed treatment and prevention initiatives in addressing the escalating burden of diabetes in Malaysia.

Klinik Kesihatan (KK) Seremban in Jalan Rasah was selected as the study’s recruitment centre, as the incidence of diabetes amongst adults aged above 18 in Negeri Sembilan is the highest at 33.2 percent, while the IMU Institute of Research, Development and Innovation (IRDI) will serve as the study’s coordination centre and storage facility for biological specimens. Diabetic patients registered with the Diabetes Registry of KK Seremban will be invited to participate in the study along with their adult family members on a voluntary basis.

The study participants’ personal and medical information will be collected through a comprehensive questionnaire by using digital systems and data infrastructure. The information includes basic sociodemographic data, anthropometric measurements, medical history, dietary habits, physical activity, laboratory tests such as haematological profile, blood glucose profile, kidney and liver function tests, socioeconomic information, and psychosocial health. Blood samples will also be taken for genetic profiling to study individual predisposition to diabetes and, for diabetic patients, predisposition to complications and response to medications and physical and dietary interventions.

Over 10,000 participants will be recruited for this study over a period of 3 years beginning July 2023. Subsequently, regular follow-ups will be conducted with each participant, and the process of data collection will be repeated every 3 years over a span of 12 years to assess the occurrence of diabetes and the emergence of new diabetes-related complications. Additionally, information on life events such as hospital admissions and deaths for each participant will be collected and updated annually.

In line with the aim of establishing SeDia Cohort as a study of national significance, local and international researchers will be granted access to SeDia Cohort data for further analysis and studies, subject to the approval of the Medical Research and Ethics Committee (MREC), of MOH’s National Institutes of Health (NIH). This is crucial to maximize research and development resources, both domestic and international, to gain a comprehensive understanding of this complex disease and develop specific intervention strategies for individuals and communities as well as contribute to shaping the future of diabetes management at the national level.

Most studies on diabetes are short-term in nature and examine individual factors of significance in isolation. Many large-scale diabetes cohort studies are conducted in populations distinct from Malaysia and their findings may not be directly relevant to the local population. Therefore, the SeDia Cohort study provides an opportunity for researchers to gain a deeper understanding of the role of genetics and the environment within the local community. Consequently, it can further improve diabetes management guidelines and public health policies towards better health outcomes.

Due to the extensive scope of the SeDia Cohort study, which involves a large participant pool over a long duration, substantial funding is required. The study will be funded through public funds, including contributions from corporations and individuals.

Chronology of events
The Memorandum of Understanding between MOH and IMU for the establishment of the SeDia Cohort Study was signed on 17 May 2022 while the research protocol obtained the approval of MREC on 17 March 2023.

The SeDia Cohort Study was officially launched in July 2023 by the Yang Di Pertuan Besar Negeri Sembilan, Tuanku Muhriz ibni Almarhum Tuanku Munawir, and attended by Health Minister Dr Zaliha Mustafa and Vice-Chancellor and Chief Executive Officer of IMU, Professor Dr Abdul Aziz Baba.

In conjunction with the official launch of SeDia Cohort, a 1-day symposium titled Precision Medicine in Diabetes was organized. Among the symposium speakers were Professor Datuk Dr Lokman Hakim Sulaiman, Deputy Vice-Chancellor of Research at IMU and principal investigator of SeDia Cohort, as well as four members of the Scientific Advisory Committee of SeDia Cohort, namely Professor Dato’ Dr Mafauzy Mohamed, consultant endocrinologist and member of the IMU Board of Governors; Professor Datuk Dr Abdul Rahman Abdul Jamal, Senior Fellow at the UKM Medical Molecular Biology Institute (UMBI); Datuk Dr Zanariah Hussein, consultant endocrinologist, Hospital Putrajaya, and Professor Dr Edward Gregg, Imperial College London.

Facts and figures of diabetes in Malaysia
·       An estimated 3.9 million Malaysian adults are affected by diabetes. [National Health and Morbidity Survey (NHMS) 2019. Available at: https://iku.gov.my/images/IKU/Document/REPORT/NHMS2019/FactSheet_BI_AUG2020.pdf. Accessed on 13 July 2023.]

·       Malaysia has the highest incidence of diabetes in the Asia-Pacific region and amongst the highest in the world. [PLoS ONE 2022;17(1):e0263139]

·       The prevalence of diabetes has shown a steady upward trend, from 11.2 percent in 2011 to 18.3 percent in 2019 as documented by the NHMS in 2011 and 2019. [NHMS 2011. Available at: https://iku.gov.my/images/IKU/Document/REPORT/NHMS2011-VolumeII.pdf. Accessed on 13 July 2023, NHMS 2019. Available at: https://iku.gov.my/images/IKU/Document/REPORT/NHMS2019/FactSheet_BI_AUG2020.pdf. Accessed on 13 July 2023]

·       By 2025, it is projected that about 11 million adults in Malaysia will have diabetes, representing a significant healthcare burden on the nation. [Int J Environ Res Public Health 2021;18(1):318]

·       The cost of treatment for diabetes patients, not including the cost of treatment for diabetes complications, is estimated at around RM3 billion per year. [Int J Environ Res Public Health 2020;17(16):5723]