Clinical trial NCT05642533: Obesity and Cardiovascular Diseases, Cross-sectional Study in Saudi Arabia
Official title: Obesity and Cardiovascular Diseases, Cross-sectional Study in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity and Cardiovascular Risk
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 1144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults with obesity, either without a history of T2D (Cohort 1) or with a history of T2D (Cohort 2).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Signed consent obtained before any study related activities (study related activities are any procedure-related to recording of data according to the protocol).
2. 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).
3. Diagnosed with T2D for patients in Cohort 2.
4. Male or female, aged between 18 and 75 years at the time of signing informed consent

Exclusion Criteria:

1. Participation in an interventional clinical trial during the study period.
2. Diagnosed with T2D for patients in Cohort 1.
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Primary outcomes:
measure: Proportion of people with obesity without a history of Type 2 diabetes (T2D) who have Cardiovascular disease (CVD)s (pre-existing or newlydiagnosed)
timeFrame: At time of patient enrollment/cross-sectional routine visit (DAY 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ahsa
country: Saudi Arabia
facility: King Abdulaziz Hospital-Al Ahsa-National Guard
city: Dammam
country: Saudi Arabia
facility: King Fahad Military Medical Complex in Dhahran
city: Jeddah
country: Saudi Arabia
facility: Dr Soliman Fakeeh Hospital
city: Jeddah
country: Saudi Arabia
facility: King Abdul Aziz University Hospital - Jeddah
city: Riyadh
country: Saudi Arabia
facility: King Khaled University Hospital,King Saud Univ. Med. City
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: