Skip to main content
Clinical Trials/NCT05642533
NCT05642533
Completed
Not Applicable

Obesity and Cardiovascular Diseases, Cross-sectional Study in Saudi Arabia

Novo Nordisk A/S0 sites1,061 target enrollmentDecember 31, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity and Cardiovascular Risk
Sponsor
Novo Nordisk A/S
Enrollment
1061
Primary Endpoint
Proportion of people with obesity without a history of Type 2 diabetes (T2D) who have Cardiovascular disease (CVD)s (pre-existing or newlydiagnosed)
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 31, 2022
End Date
September 14, 2023
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Outcomes

Primary Outcomes

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 \[CI\])

Similar Trials