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The H3A Diabetes Study: A multi-centre study of the prevalence and environmental and genetic determinants of type 2 diabetes in sub-Saharan Africa. (Field Data collection 2015-2018)

South Africa, 2015 - 2018
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Reference ID
H3A.Clinical.and.Population.Dataset.2021.v1
Producer(s)
Motala Ayesha†, Adebamowo Clement, Balde Naby, Kaleebu Pontiano, Kapiga Saidi, Levitt Naomi, Mayige Mary, McCarthy Mark, Nyirenda Moffat , Heyderman Robert, Oli John, Rotimi Charles, Sandhu Manjinder, Sobngwi Eugene, Smeeth Liam, Kenneth Ekoru, † Lead Principal investigator
Metadata
Documentation in PDF DDI/XML JSON
Created on
May 12, 2021
Last modified
May 12, 2021
Page views
74579
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296
  • Study Description
  • Data Dictionary
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  • Scope
  • Coverage
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  • Data collection
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  • Identification

    Survey ID number

    H3A.Clinical.and.Population.Dataset.2021.v1

    Title

    The H3A Diabetes Study: A multi-centre study of the prevalence and environmental and genetic determinants of type 2 diabetes in sub-Saharan Africa. (Field Data collection 2015-2018)

    Country
    Name Country code
    South Africa ZA
    Abstract

    Objective
    The objective of the study is to assess the burden and the spectrum of environmental and genetic determinants of T2D and selected associated microvascular complications in SSA.
    Methods
    A multi-national study integrating epidemiological and genomic techniques designed as case-series and population based cross-sectional surveys at 10 sites in 7 countries spanning west, east and southern Africa. Up to 6000 cases of T2D from health facilities and 6000 population based controls will be recruited. This design makes it possible to efficiently draw cases of T2D from health facilities and align them to controls from an appropriate base population while providing an opportunity to estimate prevalence from the survey component of the study. The integrated approach provides a framework for assessing burden, spectrum, and environmental and genetic risk factors for T2D and associated clinical complications.

    Kind of Data

    Includes data on:Socio-demographic, biophysical and anthropometric, biochemical factors as well as fundus image grading.

    Unit of Analysis

    The unit of analysis is the human individual. Each record corresponds to an individual.

    Version

    Version Description

    V1.0.0

    Scope

    Topics
    Topic Vocabulary URI
    Diabetes Mellitus, Type 2 Africa Health Research Institute www.ahri.org
    Keywords
    Type 2 Diabetes Mellitus, Sub-Saharan Africa, Epidemiology, Genetics

    Coverage

    Geographic Coverage

    Cameroon, Guinea, Malawi, Nigeria, South Africa, Tanzania, Uganda

    Universe

    The population in both the survey and clinic arms of the study was of self-identified black Africans, 18 years or older and resident in their respective localities. The inclusion and exclusion criteria are in the table below.

    Inclusion and Exclusion criteria

    Clinic Arm
    Inclusion
    Age=>25 years. Clinically diagnosed T2D based on data extracted from patient medical records according to current ADA and WHO definitions.
    Fasting plasma glucose (FPG) =>7.0mmol/ (=>126mg/dl) OR o Two-hours post-load glucose (2h-PG) =>11.1 mmol/l (=>200mg/dl) OR o Symptoms of diabetes and random plasma glucose => 11.1 mmol/l (=200mg/dl) OR o On oral or insulin treatment for diabetes. Individual of African origin (Black) Signed informed consent.

    Exclusion
    · Pregnant women - can participate six months after childbirth
    · Diabetes classified other than T2D or doubt as to classification
    · Living outside the geographical sampling frame for the relevant site
    · Self-defined ethnic group regarded as other than African (Black)
    · Unable to give informed consent

    Survey Arm
    Inclusion
    Resident in the relevant geographical sampling frame
    Age=>18 years · Individual of African origin (Black)
    Signed informed consent

    Exclusion
    · Pregnant women - can participate six months after childbirth
    · Resident outside the relevant geographical sampling frame
    · Self-defined ethnic group regarded as other than African (Black)
    · Unable to give informed consent

    Producers and sponsors

    Primary investigators
    Name Affiliation
    Motala Ayesha† Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban
    Adebamowo Clement Institute of Human Virology, Abuja
    Balde Naby CHU Donka, University of Conakry
    Kaleebu Pontiano MRC/UVRI Unit Uganda
    Kapiga Saidi Mwanza Intervention Trials Unit/NIMR Tanzania
    Levitt Naomi Faculty of Health Sciences, University of Cape Town
    Mayige Mary National Institute for Medical Research, Dar es Salaam
    McCarthy Mark Wellcome Trust Centre for Human Genetics; MRC Centre for Global Health Genomics, Oxford University
    Nyirenda Moffat , Heyderman Robert Malawi-Liverpool-Wellcome Trust Unit, Blantyre
    Oli John University of Nigeria Teaching Hospital, Enugu
    Rotimi Charles National Human Genome Research Institute, National Institutes of Health
    Sandhu Manjinder University of Cambridge
    Sobngwi Eugene University of Yaoundé 1
    Smeeth Liam London School of Hygiene and Tropical Medicine
    Kenneth Ekoru US National Institutes of Health
    † Lead Principal investigator
    Producers
    Name
    Africa Health Research Institute
    Funding Agency/Sponsor
    Name Role
    Wellcome Trust Funder
    Other Identifications/Acknowledgments
    Name Affiliation Role
    Kenneth Ekoru US National Institutes of Health Programme Manager
    Nelisiwe Mtshali Africa Health Research Institute Data manager
    Teniola Akeredolu Institute of Human Virology, Abuja Study coordinator
    Jean Claude Katte University of Yaoundé 1 Study coordinator
    Gibson Kagaruki National Institute for Medical Research, Dar es Salaam Study coordinator
    Nonhlanhla Nombula Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban Study coordinator
    Christian Okafor University of Nigeria Teaching Hospital, Enugu Study coordinator
    Mamadou Cherif Diallo CHU Donka, University of Conakry Study coordinator
    Odala Chithodwe Malawi-Liverpool-Wellcome Trust Unit, Blantyre Study coordinator
    Asungushe Kayombo Mwanza Intervention Trials Unit/NIMR Tanzania Study coordinator
    Clara Wekesa MRC/UVRI Unit Uganda Study coordinator
    Linda Visser Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban Retinopathy grading lead
    Sureyah Nassimbwa MRC/UVRI Unit Uganda Laboratory coordinator
    Peter Hughes MRC/UVRI Unit Uganda Laboratory head
    Mia Crampin Malawi-Liverpool-Wellcome Trust Unit, Blantyre Site Co-PI
    Bonginhlanhla Ernest Mbambo Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban Finance officer
    Dickman Gareta Africa Health Research Institute Head:Research Data Management
    Keabetswe Dikgale Africa Health Research Institute Research Data Manager

    Sampling

    Sampling Procedure

    T2D cases were recruited purposively selected from health facilities within the geographical location of study centres using patient registers as sampling frames. Surveys were conducted in the catchment areas of the selected health facilities using a two-stage cluster sampling design involving predefined geographical areas such as administrative units and households. Listings of administrative units and households were obtained from each country's National Statistics Office or equivalent agency, or generated with the help of a local leader of the area to provide a sampling frame.

    Data collection

    Dates of Data Collection
    Start End
    2015-01-01 2018-12-04

    Data Access

    Access conditions

    The representative of the Receiving Organization agrees to comply with the following conditions:

    1. Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
    2. Copies of the restricted data or any data created on the basis of the original data will not be copied or made available to anyone other than those mentioned in this Data Access Agreement, unless formally authorized by the Data Archive.
    3. The data will only be processed for the stated statistical and research purpose. They will be used for solely for reporting of aggregated information, and not for investigation of specific individuals or organizations. Data will not in any way be used for any administrative, proprietary or law enforcement purposes.
    4. The Lead Researcher must state if it is their intention to match the restricted microdata with any other micro-dataset. If any matching is to take place, details must be provided of the datasets to be matched and of the reasons for the matching. Any datasets created as a result of matching will be considered to be restricted and must comply with the terms of this Data Access Agreement.
    5. The Lead Researcher undertakes that no attempt will be made to identify any individual person, family, business, enterprise or organization. If such a unique disclosure is made inadvertently, no use will be made of the identity of any person or establishment discovered and full details will be reported to the Data Archive. The identification will not be revealed to any other person not included in the Data Access Agreement.
    6. The Lead Researcher will implement security measures to prevent unauthorized access to licensed microdata acquired from the Data Archive. The microdata must be destroyed upon the completion of this research, unless the Data Archive obtains satisfactory guarantee that the data can be secured and provides written authorization to the Receiving Organization to retain them. Destruction of the microdata will be confirmed in writing by the Lead Researcher to the Data Archive.
    7. Any books, articles, conference papers, theses, dissertations, reports, or other publications that employ data obtained from the Data Archive will cite the source of data in accordance with the citation requirement provided with the dataset.
    8. An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.
    9. The original collector of the data, the Data Archive, and the relevant funding agencies bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
    10. This agreement will come into force on the date that approval is given for access to the restricted dataset and remain in force until the completion date of the project or an earlier date if the project is completed ahead of time.
    11. If there are any changes to the project specification, security arrangements, personnel or organization detailed in this application form, it is the responsibility of the Lead Researcher to seek the agreement of the Data Archive to these changes. Where there is a change to the employer organization of the Lead Researcher this will involve a new application being made and termination of the original project.
    12. Breaches of the agreement will be taken seriously and the Data Archive will take action against those responsible for the lapse if willful or accidental. Failure to comply with the directions of the Data Archive will be deemed to be a major breach of the agreement and may involve recourse to legal proceedings. The Data Archive will maintain and share with partner data archives a register of those individuals and organizations which are responsible for breaching the terms of the Data Access Agreement and will impose sanctions on release of future data to these parties.
    Citation requirements

    Motala, A., Adebamowo, C., Balde, N., Kaleebu, P., Kapiga, S., Levitt, N., Mayige, M., McCarthy, M., Nyirenda, M., Heyderman, R., Oli, J., Rotimi, C., Sandhu, M., Sobngwi, E., Smeeth, L., & Ekoru, K. (2021). The H3A Diabetes Study: A multi-centre study of the prevalence and environmental and genetic determinants of type 2 diabetes in sub-Saharan Africa. (Field Data collection 2015-2018) [Data set]. Africa Health Research Institute (AHRI). https://doi.org/10.23664/H3A.CLINICAL.AND.POPULATION.DATASET.2021.VERSION.1

    Metadata production

    DDI Document ID

    DDI.H3A.Clinical.and.Population.Dataset.2021.v1

    Producers
    Name
    Africa Health Research Institute
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