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临床试验/NCT05642533
NCT05642533已完成不适用

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

Novo Nordisk A/S0 个研究点目标入组 1,061 人开始时间: 2022年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,061
主要终点
Proportion of people with obesity without a history of Type 2 diabetes (T2D) who have Cardiovascular disease (CVD)s (pre-existing or newlydiagnosed)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Proportion of people with obesity without a history of Type 2 diabetes (T2D) who have Cardiovascular disease (CVD)s (pre-existing or newlydiagnosed)

时间窗: At time of patient enrollment/cross-sectional routine visit (DAY 1)

Percentage (and 95% confidence interval \[CI\])

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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