Obesity and Cardiovascular Diseases, Cross-sectional Study in Saudi Arabia (OCCURS)
The purpose of this research study is to collect information on participants body weight, blood sugar levels, heart related diseases and lifestyle. The collected information will help estimate the prevalence of participants disease.
This study will take about 6 months. However, participants involvement in the study will not extend beyond their routine visit and will thus require a maximum of 1 day.
If participants choose to take part, they will be asked to give information about their health in routine clinical visit. Participants will be asked to complete a questionnaire about their lifestyle. Participants will complete this questionnaire during their normally scheduled visit with their doctor. Participants will continue their normal way of life and will not get any medication other than those prescribed to them by their doctor.
Participants will have no direct benefit from participation in this study and there are no risks involved.
Participants decide voluntarily whether they want to participate in this study or not. Participants' decision will not affect their medical care and they do not have to justify their decision.
Participants are free to leave the study at any time and without giving reasons. This does not affect their current or future treatment. The data collected up to that point are still being evaluated.
There is no additional cost to participants for being in this study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Al Ahsa, Saudi Arabia, 36428
- King Abdulaziz Hospital-Al Ahsa-National Guard
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Dammam, Saudi Arabia, 34313
- King Fahad Military Medical Complex in Dhahran
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Jeddah, Saudi Arabia, 23323
- Dr Soliman Fakeeh Hospital
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Jeddah, Saudi Arabia, 80215
- King Abdul Aziz University Hospital - Jeddah
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Riyadh, Saudi Arabia, 12372
- King Khaled University Hospital,King Saud Univ. Med. City
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed consent obtained before any study related activities (study related activities are any procedure-related to recording of data according to the protocol).
- Diagnosed with obesity (BMI higher than or equal to 30 for all ethnic groups except Asian; BMI higher than or equal to 27.5 for patients of Asian ethnicity).
- Diagnosed with T2D for patients in Cohort 2.
- Male or female, aged between 18 and 75 years at the time of signing informed consent
Exclusion Criteria:
- Participation in an interventional clinical trial during the study period.
- Diagnosed with T2D for patients in Cohort 1.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Without a history of Type 2 diabetes
Adults with obesity
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No treatment given
|
|
With a history of Type 2 diabetes
Adults with obesity
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No treatment given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of people with obesity without a history of Type 2 diabetes (T2D) who have Cardiovascular disease (CVD)s (pre-existing or newlydiagnosed)
Time Frame: At time of patient enrollment/cross-sectional routine visit (DAY 1)
|
Percentage (and 95% confidence interval [CI])
|
At time of patient enrollment/cross-sectional routine visit (DAY 1)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAS-7510
- U1111-1279-3716 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
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