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临床试验/NCT02416440
NCT02416440已完成不适用

Durban Diabetes Study: A Population Based Cross-sectional Study of the Epidemiology of Diabetes Mellitus in Urban South Africans of African Descent

University of KwaZulu1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,200
试验地点
1
主要终点
prevalence of diabetes mellitus and associated cardiometabolic and infectious risk factors using the oral glucose tolerance test

研究概览

简要总结

Type 2 diabetes (T2D) is an emerging epidemic in sub-Saharan Africa, with an estimated prevalence of 6%. With around seven million cases of T2D in 2000, it is anticipated that over 18 million Africans will have the disease by 2030. In South Africa the prevalence of T2D in people of African descent has been reported to be between 3-10%. However, there have been limited studies on diabetes epidemiology in South Africans using currently employed World Health Organization (WHO) criteria.

To assess the burden of T2D and associated risk factors in South Africa, we are establishing the Durban Diabetes Study (DDS) - a population-based cross-sectional study in the city of Durban (the eThekwini municipality) to be undertaken in 1,200 participants of African descent. In-depth health questionnaire responses, biophysical measurements and blood and urine samples will be gathered from these participants. These data will allow researchers to estimate the population prevalence of T2D and associated risk factors in the region. The infrastructure created for this cross sectional study has the potential to serve as a strong framework for future research initiatives and public health interventions within the region.

详细描述

STUDY OBJECTIVES

  • To estimate the prevalence of diabetes mellitus and associated cardiometabolic and infectious risk factors in this population
  • To provide aetiological insights into the variation in cardiometabolic and infectious risk factors in adults using both population genetic and epidemiological approaches
  • To compare diagnostic tests for diabetes in this population
  • To create a unique framework for building a large scale cross sectional study in an African population to examine a wide range of health indices-and lay the groundwork for additional long-term studies
  • to inform health policy and public health programmes aimed at addressing the rise in non-communicable diseases (NCDs) in South Africa, which may also shape public health strategies in other African countries

STUDY DESIGN

The DDS involves a number of stages:

Stage 1: Geographical sampling frame The eThekwini Municipality (city of Durban) is selected as the initial sampling frame and broken down into nine planning unit clusters (PUCs), representing nine townships (Umlazi, Inanda, KwaMashu, Ntuzuma, Mpumalanga Complex, Cato Manor, Clermont, Lamontville and Chesterville) totalling a population of approximately 1,378,750 individuals. Streets are randomly selected in each PUC proportional to the PUC size and the proportion of formal and informal housing in each PUC. Households are selected by systematic cluster sampling of homes located on the randomly selected streets.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

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

入选标准

  • African descent
  • aged 18 years or older
  • not pregnant
  • currently residing in Durban (eThekwini Municipality)

排除标准

  • non- African descent
  • not currently residing in Durban (eThekwini Municipality)

结局指标

主要结局

prevalence of diabetes mellitus and associated cardiometabolic and infectious risk factors using the oral glucose tolerance test

时间窗: 1 year

次要结局

  • aetiological insights into the variation in cardiometabolic and infectious risk factors in adults using both population genetic and epidemiological approaches(1 year)
  • inform health policy and public health programmes aimed at addressing the rise in NCDs in South Africa, which may also shape public health strategies in other African countries(2 years)
  • compare diagnostic tests for diabetes (plasma glucose vs. Glycosylated Haemoglobin)(1 year)
  • create a unique framework for building a large scale cross sectional study in an African population to examine a wide range of health indices-and lay the groundwork for additional long-term studies(1 year)

研究者

发起方
University of KwaZulu
申办方类型
Other
责任方
Sponsor

研究点 (1)

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