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Trial record 6 of 240 for:    Diabetes | South Africa

Durban Diabetes Study:A Study of the Epidemiology of Diabetes Mellitus in Urban South Africans of African Descent (DDS) (DDS)

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ClinicalTrials.gov Identifier: NCT02416440
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : April 15, 2015
Cambridge University Hospitals NHS Foundation Trust
University of Oxford
University of Stellenbosch
Information provided by (Responsible Party):
University of KwaZulu

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Hyperglycemia Hereditary Diseases Glucose Intolerance Other: blood sample

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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Durban Diabetes Study: A Population Based Cross-sectional Study of the Epidemiology of Diabetes Mellitus in Urban South Africans of African Descent
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
screening for diabetes prevalence
blood samples
Other: blood sample
blood sample

Primary Outcome Measures :
  1. prevalence of diabetes mellitus and associated cardiometabolic and infectious risk factors using the oral glucose tolerance test [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. aetiological insights into the variation in cardiometabolic and infectious risk factors in adults using both population genetic and epidemiological approaches [ Time Frame: 1 year ]
  2. compare diagnostic tests for diabetes (plasma glucose vs. Glycosylated Haemoglobin) [ Time Frame: 1 year ]
  3. 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 [ Time Frame: 1 year ]
  4. 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 [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
  1. whole blood for DNA extraction and genetic analysis.
  2. EDTA whole blood for Full Blood Count and Glycosylated Haemoglobin
  3. EDTA whole blood for Hepatitis C Viral load test and RNA extraction for whole virus genome sequencing.
  4. Plain serum for liver function test, serum lipids, insulin and c-peptide, and for viral markers- HIV, Hepatitis .
  5. Sodium Fluoride tubes for plasma glucose

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
adult urban Africans (blacks) aged 18years and over living in the eThekwini Municipality (also know as the city of Durban) in the province of KwaZulu-Natal in South Africa.

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416440

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South Africa
University of KwaZulu-Natal
Durban, KwaZulu-Natal, South Africa, 4013
Sponsors and Collaborators
University of KwaZulu
Cambridge University Hospitals NHS Foundation Trust
University of Oxford
University of Stellenbosch
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Principal Investigator: Ayesha A Motala, MBChB, MD University of KwaZulu

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Responsible Party: University of KwaZulu
ClinicalTrials.gov Identifier: NCT02416440    
Other Study ID Numbers: Motala IIS# 51223- Merck
BF030/12 ( Other Identifier: UKwaZulu )
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2014
Keywords provided by University of KwaZulu:
South African
urban African
risk factors
Additional relevant MeSH terms:
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Genetic Diseases, Inborn
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases