The governance structure for data access in the DIRECT consortium: an innovative medicines initiative (IMI) project
In: Life sciences, society and policy, Band 14, Heft 1
ISSN: 2195-7819
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In: Life sciences, society and policy, Band 14, Heft 1
ISSN: 2195-7819
In: Koivula , R W , Heggie , A , Barnett , A , Cederberg , H , Hansen , T H , Koopman , A D , Ridderstrale , M , Rutters , F , Vestergaard , H , Gupta , R , Herrgard , S , Heymans , M W , Perry , M H , Rauh , S , Siloaho , M , Teare , H J A , Thorand , B , Bell , J , Brunak , S , Frost , G , Jablonka , B , Mari , A , McDonald , T J , Dekker , J M , Hansen , T , Hattersley , A , Laakso , M , Pedersen , O , Koivisto , V , Ruetten , H , Walker , M , Pearson , E & Franks , P W 2014 , ' Discovery of biomarkers for glycaemic deterioration before and after the onset of type 2 diabetes: rationale and design of the epidemiological studies within the IMI DIRECT Consortium ' , Diabetologia , vol. 57 , no. 6 , pp. 1132-1142 . https://doi.org/10.1007/s00125-014-3216-x
Aims/hypothesis The DIRECT (Diabetes Research on Patient Stratification) Study is part of a European Union Framework 7 Innovative Medicines Initiative project, a joint undertaking between four industry and 21 academic partners throughout Europe. The Consortium aims to discover and validate biomarkers that: (1) predict the rate of glycaemic deterioration before and after type 2 diabetes onset; (2) predict the response to diabetes therapies; and (3) help stratify type 2 diabetes into clearly definable disease subclasses that can be treated more effectively than without stratification. This paper describes two new prospective cohort studies conducted as part of DIRECT. Methods Prediabetic participants (target sample size 2,200-2,700) and patients with newly diagnosed type 2 diabetes (target sample size similar to 1,000) are undergoing detailed metabolic phenotyping at baseline and 18 months and 36 months later. Abdominal, pancreatic and liver fat is assessed using MRI. Insulin secretion and action are assessed using frequently sampled OGTTs in non-diabetic participants, and frequently sampled mixed-meal tolerance tests in patients with type 2 diabetes. Biosamples include venous blood, faeces, urine and nail clippings, which, among other biochemical analyses, will be characterised at genetic, transcriptomic, metabolomic, proteomic and metagenomic levels. Lifestyle is assessed using high-resolution triaxial accelerometry, 24 h diet record, and food habit questionnaires. Conclusinos/interpretation DIRECT will yield an unprecedented array of biomaterials and data. This resource, available through managed access to scientists within and outside the Consortium, will facilitate the development of new treatments and therapeutic strategies for the prevention and management of type 2 diabetes.
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The DIRECT (Diabetes Research on Patient Stratification) Study is part of a European Union Framework 7 Innovative Medicines Initiative project, a joint undertaking between four industry and 21 academic partners throughout Europe. The Consortium aims to discover and validate biomarkers that: (1) predict the rate of glycaemic deterioration before and after type 2 diabetes onset; (2) predict the response to diabetes therapies; and (3) help stratify type 2 diabetes into clearly definable disease subclasses that can be treated more effectively than without stratification. This paper describes two new prospective cohort studies conducted as part of DIRECT.
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In: Koivula , R W , Heggie , A , Barnett , A , Cederberg , H , Hansen , T H , Koopman , A D , Ridderstråle , M , Rutters , F , Vestergaard , H , Gupta , R , Herrgård , S , Heymans , M W , Perry , M H , Rauh , S , Siloaho , M , Teare , H J A , Thorand , B , Bell , J , Brunak , S , Frost , G , Jablonka , B , Mari , A , McDonald , T J , Dekker , J M , Hansen , T , Hattersley , A , Laakso , M , Pedersen , O , Koivisto , V , Ruetten , H , Walker , M , Pearson , E , Franks , P W & DIRECT Consortium 2014 , ' Discovery of biomarkers for glycaemic deterioration before and after the onset of type 2 diabetes : rationale and design of the epidemiological studies within the IMI DIRECT Consortium ' Diabetologia , vol 57 , no. 6 , pp. 1132-1142 . DOI:10.1007/s00125-014-3216-x
Aims/hypothesis The DIRECT (Diabetes Research on Patient Stratification) Study is part of a European Union Framework 7 Innovative Medicines Initiative project, a joint undertaking between four industry and 21 academic partners throughout Europe. The Consortium aims to discover and validate biomarkers that: (1) predict the rate of glycaemic deterioration before and after type 2 diabetes onset; (2) predict the response to diabetes therapies; and (3) help stratify type 2 diabetes into clearly definable disease subclasses that can be treated more effectively than without stratification. This paper describes two new prospective cohort studies conducted as part of DIRECT. Methods Prediabetic participants (target sample size 2,200–2,700) and patients with newly diagnosed type 2 diabetes (target sample size ~1,000) are undergoing detailed metabolic phenotyping at baseline and 18 months and 36 months later. Abdominal, pancreatic and liver fat is assessed using MRI. Insulin secretion and action are assessed using frequently sampled OGTTs in non-diabetic participants, and frequently sampled mixed-meal tolerance tests in patients with type 2 diabetes. Biosamples include venous blood, faeces, urine and nail clippings, which, among other biochemical analyses, will be characterised at genetic, transcriptomic, metabolomic, proteomic and metagenomic levels. Lifestyle is assessed using high-resolution triaxial accelerometry, 24 h diet record, and food habit questionnaires. Conclusions/interpretation DIRECT will yield an unprecedented array of biomaterials and data. This resource, available through managed access to scientists within and outside the Consortium, will facilitate the development of new treatments and therapeutic strategies for the prevention and management of type 2 diabetes.
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We report here the genome sequence of an ancient human. Obtained from ∼4,000-year-old permafrost-preserved hair, the genome represents a male individual from the first known culture to settle in Greenland. Sequenced to an average depth of 20×, we recover 79% of the diploid genome, an amount close to the practical limit of current sequencing technologies. We identify 353,151 high-confidence single-nucleotide polymorphisms (SNPs), of which 6.8% have not been reported previously. We estimate raw read contamination to be no higher than 0.8%. We use functional SNP assessment to assign possible phenotypic characteristics of the individual that belonged to a culture whose location has yielded only trace human remains. We compare the high-confidence SNPs to those of contemporary populations to find the populations most closely related to the individual. This provides evidence for a migration from Siberia into the New World some 5,500 years ago, independent of that giving rise to the modern Native Americans and Inuit. ; Centre for Geogenetics, the Copenhagen branch of the Sino-Danish Genomic Centre and Wilhelm Johannsen Centre for Functional Genome Research were supported by Danish National Research Foundation, the Lundbeck Foundation, and the Danish Agency for Science, Technology and Innovation. Center for Biological Sequence Analysis was supported by Villum Kann Rasmussen Fonden; Center for Protein Reseaerch by the Novo Nordisk Foundation. E.W. thanks F. Paulsen for financial support to initiate the project. E.M. thanks Estonian Science Foundation for grant 7858, and R.V. EC DGR for FP7 Ecogene grant 205419 and EU RDF through Centre of Excellence in Genomics grant. J.W. thanks the Shenzhen Municipal Government, the Yantian District local government of Shenzhen, the National Natural Science Foundation of China (30725008), Ole Romer grant from the Danish Natural Science Research Council, the Solexa project (272-07-0196), and Danish Strategic Research Council (2106-07-0021). M.Bu. acknowledges the support of the ...
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