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

November 2, 2024 updated by: Fahad Ahmed Wali, King Faisal Specialist Hospital and Research Centre Madinah

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients in the western region of Saudi Arabia

Description

Inclusion Criteria:

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

Exclusion Criteria:

age below 18 years

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

Cohorts and Interventions

Group / Cohort
CVD with type 2 diabetes
CVD without type 2 diabetes
T2DM only without CVD
No T2DM and no CVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective study
Time Frame: 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,
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Factors Evaluation
Time Frame: 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.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Model
Time Frame: 36 Months
Develop a predictive model to forecast future CVD events across various combinations of CVD and T2DM. This will provide early individualized management to improve secondary prevention. The data from this modelling work will provide key insights to support self-management via an already existing electronic patient portal.
36 Months

Collaborators and Investigators

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

Sponsor

King Faisal Specialist Hospital and Research Centre Madinah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

November 30, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 2, 2024

First Submitted That Met QC Criteria

November 2, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAC/M 2024-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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