{"doc_desc":{"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)","idno":"DDI.H3A.Clinical.and.Population.Dataset.2021.v1","producers":[{"name":"Africa Health Research Institute","abbreviation":"AHRI","affiliation":"","role":""}]},"study_desc":{"title_statement":{"idno":"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)"},"authoring_entity":[{"name":"Motala Ayesha\u2020","affiliation":"Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban"},{"name":"Adebamowo Clement","affiliation":"Institute of Human Virology, Abuja"},{"name":"Balde Naby","affiliation":"CHU Donka, University of Conakry"},{"name":"Kaleebu Pontiano","affiliation":"MRC\/UVRI Unit Uganda"},{"name":"Kapiga Saidi","affiliation":"Mwanza Intervention Trials Unit\/NIMR Tanzania"},{"name":"Levitt Naomi","affiliation":"Faculty of Health Sciences, University of Cape Town"},{"name":"Mayige Mary","affiliation":"National Institute for Medical Research, Dar es Salaam"},{"name":"McCarthy Mark","affiliation":"Wellcome Trust Centre for Human Genetics; MRC Centre for Global Health Genomics, Oxford University"},{"name":"Nyirenda Moffat , Heyderman Robert","affiliation":"Malawi-Liverpool-Wellcome Trust Unit, Blantyre"},{"name":"Oli John","affiliation":"University of Nigeria Teaching Hospital, Enugu"},{"name":"Rotimi Charles","affiliation":"National Human Genome Research Institute, National Institutes of Health"},{"name":"Sandhu Manjinder","affiliation":"University of Cambridge "},{"name":"Sobngwi Eugene","affiliation":"University of Yaound\u00e9 1"},{"name":"Smeeth Liam","affiliation":"London School of Hygiene and Tropical Medicine"},{"name":"Kenneth Ekoru","affiliation":"US National Institutes of Health"},{"name":"\u2020 Lead Principal investigator","affiliation":""}],"oth_id":[{"name":"Kenneth Ekoru","affiliation":"US National Institutes of Health","email":"","role":"Programme Manager"},{"name":"Nelisiwe Mtshali","affiliation":"Africa Health Research Institute","email":"","role":"Data manager"},{"name":"Teniola  Akeredolu","affiliation":"Institute of Human Virology, Abuja","email":"","role":"Study coordinator"},{"name":"Jean Claude Katte","affiliation":"University of Yaound\u00e9 1","email":"","role":"Study coordinator"},{"name":"Gibson Kagaruki","affiliation":"National Institute for Medical Research, Dar es Salaam","email":"","role":"Study coordinator"},{"name":"Nonhlanhla Nombula","affiliation":"Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban","email":"","role":"Study coordinator"},{"name":"Christian Okafor","affiliation":"University of Nigeria Teaching Hospital, Enugu","email":"","role":"Study coordinator"},{"name":"Mamadou Cherif Diallo","affiliation":"CHU Donka, University of Conakry","email":"","role":"Study coordinator"},{"name":"Odala Chithodwe","affiliation":"Malawi-Liverpool-Wellcome Trust Unit, Blantyre","email":"","role":"Study coordinator"},{"name":"Asungushe Kayombo","affiliation":"Mwanza Intervention Trials Unit\/NIMR Tanzania","email":"","role":"Study coordinator"},{"name":"Clara Wekesa","affiliation":"MRC\/UVRI Unit Uganda","email":"","role":"Study coordinator"},{"name":"Linda Visser","affiliation":"Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban","email":"","role":"Retinopathy grading lead "},{"name":"Sureyah Nassimbwa","affiliation":"MRC\/UVRI Unit Uganda","email":"","role":"Laboratory coordinator"},{"name":"Peter Hughes","affiliation":"MRC\/UVRI Unit Uganda","email":"","role":"Laboratory head"},{"name":"Mia Crampin","affiliation":"Malawi-Liverpool-Wellcome Trust Unit, Blantyre","email":"","role":"Site Co-PI"},{"name":"Bonginhlanhla Ernest Mbambo","affiliation":"Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban","email":"","role":"Finance officer"},{"name":"Dickman Gareta","affiliation":"Africa Health Research Institute","email":"","role":"Head:Research Data Management"},{"name":"Keabetswe Dikgale","affiliation":"Africa Health Research Institute","email":"","role":"Research Data Manager"}],"production_statement":{"producers":[{"name":"Africa Health Research Institute","affiliation":"","role":""}],"funding_agencies":[{"name":"Wellcome Trust","abbreviation":"WT","role":"Funder"}],"grant_no":"WT099316AIA"},"version_statement":{"version":"V1.0.0"},"study_info":{"keywords":[{"keyword":"Type 2 Diabetes Mellitus, Sub-Saharan Africa, Epidemiology, Genetics","vocab":"Africa Health Research Institute","uri":"www.ahri.org"}],"topics":[{"topic":"Diabetes Mellitus, Type 2","vocab":"Africa Health Research Institute","uri":"www.ahri.org"}],"abstract":"Objective\nThe 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. \nMethods\nA 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.","coll_dates":[{"start":"2015-01-01","end":"2018-12-04","cycle":""}],"nation":[{"name":"South Africa","abbreviation":"ZA"}],"geog_coverage":"Cameroon, Guinea, Malawi, Nigeria, South Africa, Tanzania, Uganda","analysis_unit":"The unit of analysis is the human individual. Each record corresponds to an individual.","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.\n\nInclusion and Exclusion criteria\n\nClinic Arm\nInclusion\t\nAge=>25 years. Clinically diagnosed T2D based on data extracted from patient medical records according to current ADA and WHO definitions.\nFasting 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.\n\nExclusion\n\u00b7 Pregnant women - can participate six months after childbirth\n\u00b7 Diabetes classified other than T2D or doubt as to classification\n\u00b7 Living outside the geographical sampling frame for the relevant site\n\u00b7 Self-defined ethnic group regarded as other than African (Black)\n\u00b7 Unable to give informed consent\n\t\nSurvey Arm\nInclusion\t\nResident in the relevant geographical sampling frame \nAge=>18 years \u00b7 Individual of African origin (Black)\nSigned informed consent \t\n\nExclusion\n\u00b7 Pregnant women - can participate six months after childbirth\n\u00b7 Resident outside the relevant geographical sampling frame\n\u00b7 Self-defined ethnic group regarded as other than African (Black)\n\u00b7 Unable to give informed consent","data_kind":"Includes data on:Socio-demographic, biophysical and anthropometric, biochemical factors as well as fundus image grading."},"method":{"data_collection":{"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_access":{"dataset_use":{"cit_req":"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","conditions":"The representative of the Receiving Organization agrees to comply with the following conditions:\n\n1. Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.\n2. 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.\n3. 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. \n4. 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.\n5. 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.\n6. 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.\n7. 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.\n8. An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.\n9. 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.\n10. 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.\n11. 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.\n12. 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."}}},"schematype":"survey","tags":[{"tag":"H3A"}]}