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Clinical Trials/NCT02416440
NCT02416440CompletedNot Applicable

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 site in 1 country1,200 target enrollmentStarted: January 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,200
Locations
1
Primary Endpoint
prevalence of diabetes mellitus and associated cardiometabolic and infectious risk factors using the oral glucose tolerance test

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

  • 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)
  • aetiological insights into the variation in cardiometabolic and infectious risk factors in adults using both population genetic and epidemiological approaches(1 year)
  • 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)

Investigators

Sponsor
University of KwaZulu
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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