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Clinical Trials/NCT06674161
NCT06674161Not yet recruitingNot Applicable

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

King Faisal Specialist Hospital and Research Centre Madinah0 sites80 target enrollmentStarted: November 30, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Primary Endpoint
Retrospective study

Study Overview

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:

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • age below 18 years

Outcomes

Primary Outcomes

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,

Secondary Outcomes

  • Risk Factors Evaluation(24 months)

Investigators

Sponsor
King Faisal Specialist Hospital and Research Centre Madinah
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fahad Ahmed Wali

Consultant, Endocrinology

King Faisal Specialist Hospital and Research Centre Madinah

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