The Impact of Type 2 Diabetes Mellitus on Cardiovascular Events in Saudi Arabia Now and Future

Not yet recruiting

• Conditions: Mortality of Patients with CVD; Mortality of Patients with CVD and T2DM; Mortality of Patients with T2DM; Mortality of Patients with Neither; Morbidity of CVD; Cardiovascular Diseases; Cardiovascular Diseases Risk

• Registration Number: NCT06674161
• Lead Sponsor: King Faisal Specialist Hospital and Research Centre Madinah

Brief Summary

Cardiovascular disease (CVD) and Type 2 diabetes mellitus (T2DM) are major global health challenges with significant morbidity and mortality. In Saudi Arabia, the prevalence of CVD and T2DM is increasing. This poses a significant burden on the healthcare system. Despite extensive global research, there remains a lack of comprehensive studies examining the combined impact of CVD and T2DM in the Saudi population, particularly in the Western region. Objectives: The primary objectives of the study are: (1) quantify the incidence and mortality rates of CVD and T2DM across various demographics in the Western region of Saudi Arabia; (2) analyse the demographic, clinical, and lifestyle factors contributing to cardiovascular risk in individuals with both conditions; (3) understand the influence of cultural, social, and religious beliefs on health behaviours related to CVD and T2DM using social media and survey data; (4) develop a predictive model for forecasting future cardiovascular events in the Saudi population; and (5) evaluate the impact of the ICD11 classification of CVD. Methodology: The project will include team of experts from King Faisal Specialist Hospital and Research Centre, Madinah, Taibah University, Islamic University of Madinah, University of Prince Mugrin, and King's College University, London. We will work under four workstreams (WS) which are: WS 1: This group will supervise the data collection, analysis and ensure efficient running of the project. WS 2: In year 1, retrospective data will be collected on the service needs, long term outcomes, and mortality of patients with CVD and T2DM, CVD only, T2DM only, and neither. Between Year 1 to 5, we will collect data prospectively using the new ICD-11 criteria. Both, retrospective and prospective data will be used to develop an artificial intelligence (AI) based predictive model. WS 3: Social media survey will be undertaken to understand health beliefs and behaviours influencing health related outcome to CVD and T2DM. WS 4: Undertake economic analyses into long-term resource utilisation and cost of care for CVD and T2DM.

Expected Outcomes:

The study is expected to provide a detailed incidence and all-cause mortality CVD and T2DM in the Western region of Saudi Arabia. This will help in identifying risk factors and predictive for CVD and understand health beliefs and behaviours in Saudi Arabia. The data will help in developing policies, guidelines and awareness programmes in collaboration with policy makers. In conclusion, this study will impact by improving epidemiological knowledge and understanding of CVD and T2DM in Saudi Arabia. The project will support the overall mission of Saudi Vision 2030 with regard to increasing the health and well-being of the population.

Detailed Description

Innoviation:

The proposed study will introduce a novel theoretical framework and methodology for comprehensive investigation of the interrelationship between the various combinations of CVD and T2DM within Saudi Arabia.

Key features of the innovative theoretical concept include:

1. Population specific focus: Our research will be focused on the population of Saudi Arabia based demographic, cultural and environmental factors influencing the incidence and outcomes of CVD and T2DM.

2. Health belief: Our study will investigate health beliefs and behaviour related to CVD and T2DM. This would involve using artificial intelligence data analytic per direct questionnaires, published literature, and social media.

3. Predictive modelling: We aim to conduct a predictive modelling and develop a functional model that predicts future CVE and diabetes related cardiovascular complications.

Key innovative methodologies and approaches include:

1. Retrospective population-based study: A large population-based retrospective study will be conducted to determine the incidence and mortality of CVD with and without T2DM. This methodology will thus provide robust epidemiological data by adjusting for possible confounders using Cox regression models in determining hazard ratios.

2. Combination of CVD with/without T2DM: The results will be compared across the four groups: individuals with no CVD and T2DM, CVD only, T2DM only, and both conditions.

3. Risk factor insight: Understanding the risk factors concerning CVD and T2DM in Saudi Arabia.

4. Using AI to evaluate health belief: Conducting large scale survey on health belief using AI to analyse data obtained from existing literature, digital resources, social media platforms, and direct questionnaires.

5. Development of predictive model for future CV events: This model will be based on detailed analysis and interpretation of collected data. This will facilitate the forecasting of disease patterns and guiding preventive approaches.

6. Collaborative approach: The project involves a collaborative effort by experts from King Faisal Specialist Hospital and Research Centre, Madinah, Taibah University, Islamic University of Madinah, University of Prince Mugrin, and King's College University, London. This multidisciplinary approach ensures a comprehensive analysis that utilises diverse expertise

Methodology:

Aims and objectives We aim to improve the lives of people with CVD, T2DM and other risk factors through innovative data collection, use of data, and design personalised and optimised management strategies. We will accomplish this by creating four workstreams (WS), which will run in parallel and work collaboratively throughout the programme.

1. Workstream 1 (WS1): We will engage with those who have suffered from CVD. They will grouped into three main groups: those with Stroke, IHD and other CVD. The three groups will be subdivided into two subcategories: those with and without T2DM. This group will have individuals who are survivors of this disease, carers, public health experts, clinicians and policymakers. This group will shape the data collection, analysis and use of the data.

2. Workstream 2 (WS2): We will work towards estimating the impact of the WHO ICD11 definition of stroke, atherosclerotic CAD and T2DM. The group will also try to understand the long-term outcome and care needs of CVD survivors both individually and as a population.

3. Workstream 3 (WS3): We will use social media, community forums and healthcare facilities to understand the health beliefs of the individual and population groups. We will try to understand the effect on the health outcome of the individual and the population of these health beliefs.

4. Workstream 4 (WS4): This stream will estimate the economic impact of care, service models, and options with the aim of improving decision-making for policymakers, survivors, and individuals at higher risk, as well as their families.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-02
• Last Update Submitted: 2024-11-02
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Study Start: 2024-11-30
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

All adult patients with available records in the western region of Saudi Arabia

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Exclusion Criteria

age below 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retrospective study	12 months	Quantify the incidence, trends, and mortality rates of CVD and T2DM across different regions and demographics in the western region of Saudi Arabia,

Secondary Outcome Measures

Name	Time	Method
Risk Factors Evaluation	24 months	* Analyse various demographic, clinical, and lifestyle factors contributing to cardiovascular risk in individuals with CVD and T2DM to indicate inequalities among different phenotypes and identify critical risk factors for targeted prevention and management.; * Understand cultural, social, and religious factors that influence health beliefs and perceptions related to CVD and T2DM using data from social media in Saudi Arabia. This will facilitate the design of culturally appropriate health interventions.