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

NCT02416440 | Completed

• 2 other identifiers: Motala IIS# 51223- MerckBF030/12
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Hyperglycemia; Hereditary Diseases; Glucose Intolerance

Keywords

South African; urban African; diabetes; prevalence; risk factors; genetics

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

screening for diabetes prevalence

blood samples

Other: blood sample

Interventions

blood sample OTHER

blood sample

screening for diabetes prevalence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of KwaZulu: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• University of Oxford: collaborator
• University of Stellenbosch: collaborator

Study Sites (1)

University of KwaZulu-Natal

Durban, KwaZulu-Natal, 4013, South Africa

Location

Related Publications (9)

• Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

  PMID: 15111519 BACKGROUND

• Mbanya JC, Motala AA, Sobngwi E, Assah FK, Enoru ST. Diabetes in sub-Saharan Africa. Lancet. 2010 Jun 26;375(9733):2254-66. doi: 10.1016/S0140-6736(10)60550-8.

  PMID: 20609971 BACKGROUND

• Motala AA, Esterhuizen T, Gouws E, Pirie FJ, Omar MA. Diabetes and other disorders of glycemia in a rural South African community: prevalence and associated risk factors. Diabetes Care. 2008 Sep;31(9):1783-8. doi: 10.2337/dc08-0212. Epub 2008 Jun 3.

  PMID: 18523142 BACKGROUND

• Levitt NS, Katzenellenbogen JM, Bradshaw D, Hoffman MN, Bonnici F. The prevalence and identification of risk factors for NIDDM in urban Africans in Cape Town, South Africa. Diabetes Care. 1993 Apr;16(4):601-7. doi: 10.2337/diacare.16.4.601.

  PMID: 8462387 BACKGROUND

• Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.

  PMID: 22079683 BACKGROUND

• McCarthy MI, Abecasis GR, Cardon LR, Goldstein DB, Little J, Ioannidis JP, Hirschhorn JN. Genome-wide association studies for complex traits: consensus, uncertainty and challenges. Nat Rev Genet. 2008 May;9(5):356-69. doi: 10.1038/nrg2344.

  PMID: 18398418 BACKGROUND

• International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care. 2009 Jul;32(7):1327-34. doi: 10.2337/dc09-9033. Epub 2009 Jun 5. No abstract available.

  PMID: 19502545 BACKGROUND

• Young F, Critchley JA, Johnstone LK, Unwin NC. A review of co-morbidity between infectious and chronic disease in Sub Saharan Africa: TB and diabetes mellitus, HIV and metabolic syndrome, and the impact of globalization. Global Health. 2009 Sep 14;5:9. doi: 10.1186/1744-8603-5-9.

  PMID: 19751503 BACKGROUND

• Negro F, Alaei M. Hepatitis C virus and type 2 diabetes. World J Gastroenterol. 2009 Apr 7;15(13):1537-47. doi: 10.3748/wjg.15.1537.

  PMID: 19340895 BACKGROUND

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

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia; Genetic Diseases, Inborn; Glucose Intolerance

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ayesha A Motala, MBChB, MD

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: April 15, 2015
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 15, 2015

Record last verified: 2014-04

Locations

ZA (1)