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临床试验/NCT07048717
NCT07048717进行中(未招募)不适用

The Mauritius and Rodrigues Non-Communicable Disease (NCD) Study

Umeå University0 个研究点目标入组 39,082 人开始时间: 2025年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
39,082
主要终点
Mortality

研究概览

简要总结

Mauritius is located in the southern Indian Ocean with a population of 1.3 million in 2023. Mauritius is a multiethnic nation with 68% South Asian, 27% African (Creole), 3% Chinese and 2% Franco Mauritians.

Seven population-based cross-sectional surveys using standardised protocols were conducted between 1987 and 2021). The participation rate has been over 85% in each survey.

At each survey, participants were interviewed about living conditions, lifestyle and health, and anthropometry and blood pressure were measured. Biochemistry including lipids and an oral glucose tolerance test (OGTT) were performed Electrocardiograms (ECG) were recorded in participants aged 35 years and older. Previous participants were followed up in 2007 and 92% were successfully traced.

Studies with identical methodology have been performed on the neighbouring island Rodrigues where the majority of the population are Creoles.

详细描述

Mauritius and Rodrigues are islands in the south-eastern part of the Indian Ocean. Major changes in lifestyle have been seen during the last fifty years, including less physical activity and introduction of a westernised diet. In parallel, the disease panorama has changed from high infant mortality and infectious diseases to lifestyle-related diseases such as cardiovascular disease and type 2 diabetes.

The population in Mauritius are descendants to immigrants from South Asia, Africa and China, i.e., approximately 60% of the world population are represented. Mauritius is probably the only developing country that has followed the development of non-communicable diseases (NCD) and associated risk factors over a long time-period and continues to do so.

In the mid-eighties, the Mauritian government initiated a study on the prevalence of type 2 diabetes and cardiovascular disease, in collaboration with WHO and international experts. Altogether seven population-based surveys have been performed between 1987 and 2021, and approximately 39 000 (!) examinations have been recorded. The intention is to repeat the survey every fifth year.

The ethnicities of the participants have been 71% South Asians (India/Pakistan), 24% Creoles (Africa) and 5% Chinese, which reflects well the ethnical distribution of the population. Previous participants were followed up in 2007 and 92% were successfully traced. Studies have also been performed on the neighbouring island Rodrigues where the majority of the population are Creoles. During the follow-up survey in 2010, 97% of the 9 700 participants were traced.

At each survey, information was given and an individual consent form was signed. See attached the local (in Mauritius) ethical approval and consent form from the Mauritius survey 2021.

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
25 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mortality

时间窗: Up to 20 years from the baseline survey

According to household interviews, death certificates from central registers at Ministry of Health and Wellness. 1. Household interviews: "Is the participant alive? If dead, do you have a copy of the death certificate? When did the participant die?" 2. Central registers: Vital status, if dead, date and cause of death from death certificates" Combining 1 and 2 will give date and cause of death. Absolute numbers and mortality rates will be reported for all and in subgroups i.e. sex, age-strata, ethnicity.

次要结局

  • Diabetes Mellitus(Up to 20 years from the baseline survey)
  • Cardiovascular disease (CVD)(Up to 20 years from the baseline survey)
  • Hypertension(Up to 20 years from the baseline survey)
  • Obesity(Up to 20 years from the baseline survey)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Soderberg

Professor, consultant

Umeå University

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