Danish National Birth Cohort (DNBC)

Transcription

1 Danish National Birth Cohort (DNBC) Application form for access to data and biological samples ref. no Project title: Genetic and epi-genetic study of children born by extremely obese mothers. Applicant: Other partners taking part in the project Names and work addresses: Name: Thorkild IA Sørensen Address: Institute of Preventive Medicine, Bispebjerg and Frederiksberg Hospital, Nordre Fasanvej 57, 2000 Frederiksberg. Ph.d. Camilla Schou Andersen, Institute of Preventive Medicine Professor Ellen Aagaard Nøhr, University of Southern Denmark and Odense University Hospital. Professor George Davey Smith, University of Bristol, UK Professor Caroline Relton, University of Bristol, UK and Newcastle University, UK. Project description (max 200 words) The description should contain 1) purpose, 2) method, material, data, 3) time schedule, 4) publishing and 5) up to 5 key words Purpose: Identification of how the genetic and epigenetic profiles together with early environmental factors interact in the development of overweight in infancy, childhood and early adolescence. Method, material, data: We would like to perform genetic and epigenetic analyses on the children (with available cord blood) from the mothers selected to the case-cohort study GOYA (1). Furthermore, data from the maternal GWAS, relevant environmental factors during pregnancy and infancy, and the children s anthropometry during infancy, childhood and pre-puberty will be included. Because we have the maternal genetic profile and hopefully get permission to perform genetic analyses on the children, it will be possible to import assumed genetic information on the father. This gives us very unique opportunities to investigate the influence from the parental genetic profile on the child s genetic risk of overweight. Time Schedule: Epigenetic analyses are planned to be performed during August/September 2013 in collaboration with George Davey Smith, Bristol. The genetic analyses are not financed yet, but an application has been sent to the Danish Strategic Research Council and will be started as soon as possible. Data analysis and writing of papers will be conducted during 2014 to Publishing: Results will be published in international peer reviewed journals 1) Nøhr EA, Timpson NJ, Andersen CS, Smith GD, Olsen J, Sørensen TIA. Severe obesity in young women and reproductive health: The Danish National Birth Cohort. PloS One 2009; 4: e8444 Key words: Genetic, epi-genetic, environment, obesity, case-cohort 1

2 Danish National Birth Cohort (DNBC) Application form for access to data and biological samples Time schedule: Projec start: Data analyses terminated : Final project report: Month July Year 2013 Month Dec Year 2015 Month Dec Year 2017 Please indicate articles planned and their approx title(s): Based on the data applied for, I plan to publish Article no 1, titel: The genetic predisposition for obesity development in infancy, childhood and pre-puberty Article no 2, titel: The parental genetic influence on the child s genetic profile and risk of obesity development in infancy, childhood and pre-puberty. Article no 3, title: Maternal gene-diet interactions, the child s methylation status at birth and obesity development in infancy, childhood and pre-puberty. Article no 4, title: Maternal gene-smoking interactions, the child s methylation status at birth and obesity development in infancy, childhood and pre-puberty. Article no 5, title:interactions between maternal genes and physical activity during pregnancy, the child s methylation status at birth and obesity development in infancy, childhood and pre-puberty. Article no 6, title: Parental genes, maternal lifestyle factors during pregnancy (diet, smoking and physical activity), the child s methylation status at birth and obesity development in infancy, childhood and pre-puberty. Project protocol enclosed: yes no Interview Data 2

3 Are you applying for interview data? no X yes Int 1 Int 2 Int 3 Int 4 x 7-year follow-up And: X Weight and height data from the 11 year follow-up Selection criteria: All children included in the GOYA project with available cord blood samples Specification of data required: (list of variables to be agreed with the DNBC data manager) No. of individuals concerned: GWAS data from the children, and data from epigenetic analyses, weight, height and waist data from the children s 7 year and 11-year follow-up. We already have all other necessary data available in the GOYA project. App children Biological Specimens 3

4 Are you applying for biological specimens? no X yes: Only a minimum quantity of blood necessary for the analyses in question will be handed out. Please note that DNA is not yet available from all participants. DNA must be extracted at Statens Serum Institut. from 1st sample quantity from 2nd sample quantity from 3rd sample (cord blood) quantity: 6 ug Please describe how your study design is adapted to make the best possible use of the biological specimens. Account for the feasibility of the analyses (requirements for transportation, treatment and storages must be taken into consideration). It is expected, that app. 5 ug DNA will be needed for the GWAS study, and around 1 ug DNA for the methylation analyses. All DNA left-overs will be delivered back to the biobank. Number of persons, selection criteria, time period: For what kind of analyses? (state purpose and method): Where are the laboratory analyses carried out?: References from the laboratory may be enclosed. All children included in the GOYA project with available cord blood samples, where there has been conducted a GWAS on the mother: app children. Epigenetic analyses will hopefully be conducted during august and September GWAS on the children will be conducted when money for this has been found research money will be applied for. Epigenetic analyses for investigation of the influence from the prenatal environment and the genetic profile in relation to development of overweight in the children. The GWAS analyses will be conducted to investigate genetic polymorphisms in the two groups of children, to investigate the interaction between the genetic profile and the early environment, and to investigate the complex network of parental and child genetic profile (because we have the GWAS from the mothers and at some point from the children, it will be possible to impute genetic information from the father). The epigenetic analyses will be carried out at the University of Bristol at our collaborator s lab leaded by George Davey Smith. Supplementary Data Collection Sample analyses results 4

5 Will you be collecting supplementary data/biological samples from cohort members, or will new analyses data be generated? In you application to the Danish Data Protection Agency (DDPA) remember to state that you will return supplementary data to the DNBC X No Yes Supplementary data and results from biological analyses, including genome-wide scans must after approval from the DDPA - be returned to the DNBC database and be made available for other scientists. If you are contacting DNBC participants by mail, this contact must be initiated by the DNBC secretariat. Which kind of data/biological samples? interview/questionnaire (to be enclosed) linkage with other registries (please specify) biological specimens (please specify) How many individuals will be concerned? During which time period will collection take place? Other Approvals Is your project/data collection approved by: Danish Biomedical Research Ethics Committee yes (copy of approval to be enclosed) X no but application has been sent The Danish Data Protection Agency yes (copy of approval to be enclosed) X no but application has been sent Finances 5

6 The invoice for the data file should be sent to: Name: Thorkild I.A. Sørensen Address: Institute of Preventive Medicine,Nordre Fasanvej 57, 2000 Frederiksberg. Is the project fully financed? X No, not yet the whole project but for the epigenetic analyses, financing has been found, please see below. Yes, amount: Name of the funding person/organisations: The costs for the epi-genetic analyses will be covered by George Davey Smith, and the costs for the transportation of the samples will be paid by The Institute of Preventive Medicine. Date and signature Date and signature: 14. juni 2013 Thorkild IA Sørensen (udfyldt af post. Doc Camilla Schou Andersen, Institute of Preventive Medicine. Save the application form to your harddisk and mail to IKM@ssi.dk together with your protocol and other relevant documentation. 6