| Name | LifeLines Cohort Study & Biobank |
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| Acronym | LifeLines |
| Last update | 03/23/2009 |
Affiliation
Principal investigator
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Bruce HR Wolffenbuttel (Scientific Director)
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University Medical Centre Groningen |
Contact
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Bruce HR Wolffenbuttel (Scientific Director)
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University Medical Center Groningen
Groningen P.O. Box 30001 Phone: +31-50-3613962 Email: bwo@int.umcg.nl |
Website
Funding agency
| Percentage | Category | |
|---|---|---|
| Dutch Diabetes Research Foundation | -- | Charity |
| Governement, 3 northern provinces of The Netherlands | 35% | Governmental funding |
| University Med Center Groningen/ University of Groningen | 44% | -- |
| The Netherlands Organization for Scientific Research (NWO) | 16% | Public Research Funding |
| Dutch Kidney Foundation | -- | Charity |
Multifactorial diseases are by definition the result of multiple risk factors that are both genetically and environmentally determined. Multifactorial diseases may have more in common than generally recognized, since some risk factors are associated with multiple diseases, suggesting an individual susceptibility for specific risk factors.
Since different diseases share identical risk factors, it is clear that an exclusive focus on associations between single risk factors and single outcomes will not unravel the unresolved issues of aetiology and individual prognosis of multifactorial diseases. Instead, research has to focus on the underlying mechanisms why individuals with similar (established) risk factors develop different diseases, i.e. the modification of the universal risk factors for multiple disorders.
Overall aim of the study:
Unravel the interaction between genetic and environmental factors in the development of multifactorial diseases, their concurrent development in individuals and their complications as a complex trait.
Primary objectives:
Which are the disease overriding risk factors which predict the development of a multifactorial disease during lifetime? How are these universal risk factors modified, or what determines the effect of a universal risk factor in an individual? Specific research questions will focus on risk factors and modifiers (genetic, environmental and combined or complex factors) for single and multiple diseases. In addition to co-morbidity, LifeLines focuses on co-determinants. The primary endpoints include measures of ageing, metabolic and endocrine diseases, cardiology, renal diseases, pulmonary and musculoskeletal diseases, and psychopathology.
Secondary objectives:
Secondary aims include the assessment of the prevalence and incidence of multifactorial diseases and their risk factors in individuals as well as in families. The burden of disease for the society will be quantified in terms of care needed, and total costs of care.
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Supplementary informations
General focus on frequently occurring multifactorial disorders and multidisease factors
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Legend
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| Study design | Cohort |
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| Type of participants | Individuals, Families |
| Supplementary informations | The study population consists of a representative sample of the population of the northern provinces of the Netherlands (Friesland, Groningen and Drenthe), existing of 165,000 persons in three generations. These include 55,000 in the age group > 50 yrs, 75,000 in the age group between 25 and 50, and 35,000 in the age group below 25 yrs. |
| Target or final number of participants | 165000 |
| The project will include 165.000 participants: 30.000 probands, 20.000 partners, 75.000 parents (in law) and 40.000 children. | |
| Target or final number of families | 30000 |
| Target or final number of DNA | 165000 |
Selection criteria
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Minimun: 25 years Maximun: 50 years |
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Netherlands (Three Northern provinces: Groningen, Friesland and Drenthe) |
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Being able to speak Dutch. |
Recruitment procedures
The study population consists of a representative sample of the population of the northern provinces of the Netherlands (Friesland, Groningen and Drenthe), existing of 165,000 persons.
Persons registered in a general practitioner’s practice in Groningen, Friesland and Drenthe, between 25 and 50 years of age. After inclusion of the proband, the partners, parents, parents in law and children of these participants will be asked to participate in the study.
The recruitment of participants will be carried out in a selected number of medical practices. All patients in a medical practice, in the age range of 25-50 years, will be asked to join the study. Via information obtained from the medical practice, individuals will be asked by mail to participate in the cohort study. In the Netherlands, the average general practice size is around 2,000-2,400 patients, although combined or group practices may be larger. In the pilot study, it was learned that about 35 - 40% of the eligible population from each practice will participate. It is estimated that around 135,000 individuals in the age category of 25-50 years will need to be approached to provide the required sample of 45,000 index participants.
The participating practices will be selected from interested rural and municipal practices within the three Northern provinces, and care is taken that they represent all socioeconomic layers of the population. They are considered eligible to take part in the study if they have an interest in research and use computerised patient and prescription records. Over 80% of practices in The Netherlands use such computer programs. Practices will be selected so as to cover a broad range of socio-economic conditions. In case selected practices have insufficient space for performing the LifeLines related activities, the evaluation of participants and their follow-up may be organized through municipal health centres or corresponding facilities (dedicated Research sites) in the vicinity of the G.P. practice(s), which will be set up through the University Medical Centre Groningen.
Data Sources
| Cross-sectional | Repeated/continuous | |
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Collection procedures
Intake visits to General Practitioner or Research Site
During the first visit the signed informed consent is taken in. If requested, additional information will be provided.
During the first and second visit, the first or second part of the questionnaire, respectively, are taken in and checked for completeness, a number of investigations are conducted and blood and urine samples are taken (see below). The second visit is scheduled approximately 2 weeks after the first visit, depending on available time and preference of the participant.
For participants of 65 years and older, a MMSE (minimal mental state examination) will be conducted in order to determine the capabilities of the participant. An adapted program or visits at home by the research nurse will be conducted; a decision to do so is at the discretion of the participating general practitioner. In principle, the adapted program will identical to the standard program instead that the questionnaires will be divided in several parts. Additionally, for all participants, investigations will not be performed when the participant is physically or mentally not capable in the performance of one or more specific investigations, a decision to do so is at the discretion of the research nurse.
The participant is asked to fill the questionnaire in at home (on paper or online), and to return the paper versions by mail or to deliver it at the first scheduled visit. If there are problems filling in the questionnaire, LifeLines personnel can be contacted for assistance. The baseline questionnaire comprises Demographics, Family composition, Work and educational level, Health, Questions for females, Birth and development, Lifestyle and diet, Day time spending, Living environment, Quality of life, Health perception, Personality, Stress and Social support
Measurements comprise amongst others Anthropometric measures: height, weight, hip and waist circumference, Blood pressure: using a DINAMAP, measurements during 10 minutes, 12-lead electrocardiogram (ECG), Pulmonary function tests (FEV1 and VC), Ruffs Figure Fluency Test (RFFT): test of cognitive function, MINI interview: neuropsychiatric interview in which a number of basic questions are asked about fears and depression.
Second visit comprises Fasting venapuncture, Measurement of skin autofluorescence with a non-invasive AGE-reader (Advanced Glycation Endproducts), 24 hour urine, First morning urine.
Follow up procedures
Yearly, the participants will receive a questionnaire, consisting of incidence of diseases / visits to health care providers, Medication use, Additional information on health determinants, e.g. nutrition.
Every 4-5 years participants are invited for a visit to the general practitioner or research site. These follow-up visits include blood sampling, urine collection and measurements like the baseline measurements. A questionnaire comparable to the baseline questionnaire is used. Maximal efforts will be used to have follow-up examinations in most participants.
Baseline principal variables of interest
Health information
Physical / Biochemical measures
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Sociodemographic Characteristics
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Socioeconomic Characteristics
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Life habits / Behaviours
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Physical environment
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Sample management
Biological samples
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Biological samples format
| Fresh | Frozen | Dried (paper) | Other | Specification | |
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| Blood |
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| Cell lines |
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Legend
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Allow access to data or samples to external researchers
| Academia | Industry | |
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Current status
| Phase | Start | End |
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| Preparation phase/Pilot | 2004 | 2006 |
| Recruitment / initial data collection | 2007 | 2011 |
| Follow-up of participants | 2012 | 2015 |
| Study ended | 2036 |
| Current number of participants recruited | 20000 in date of 05/01/2008 |
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| Current number of collected DNA samples | 20000 in date of 05/01/2008 |
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| Participation rate | 35% |
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| Document type | Availability | |
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| 1 | General study protocol |
bwo@int.umcg.nl |
| 2 | Specific protocols/procedures (data collection, samples management, etc.) |
bwo@int.umcg.nl |
| 3 | Questionnaires |
bwo@int.umcg.nl |
| 4 | Physical and cognitive measures | |
| 5 | DNA processing | |
| 6 | Consent forms |
bwo@int.umcg.nl |
| 7 | Pamphlet / project description |
bwo@int.umcg.nl |
| 8 | Governance / ethics documentation | |
| 9 | Other |
Funding for baseline measurement and partly for follow-up has been obtained
| Name | LifeLines Questionnaire |
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| Last update | 01/06/2010 |
| Phase | Baseline |
Contact
No information available. See study information.
Available Format
NOTICE: HTML document format may differ slightly from the actual questionnaire. Please refer to the original PDF document for exact reproduction.
| Name | LifeLines Questionnaire |
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| Number of Question Blocks | 62 |
| Name | Physical and Cognitive Measures |
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| Last update | 07/27/2009 |
| Collected at phase | Baseline |
Contact
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Bruce HR Wolffenbuttel (Scientific Director)
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University Medical Center Groningen
Groningen P.O. Box 30001 Phone: +31-50-3613962 Email: bwo@int.umcg.nl |
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Legend
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Other body structure measures
(Measurement of skin autofluorescence with a non-invasive AGE-reader (Advanced Glycation Endproducts))
Cognitive functions (Ruffs Figure Fluency Test (RFFT))
Other global mental functions (e.g. IQ)
(MMSE (minimal mental state examination) for participants of 65 years and older)
Other specific mental functions
(Neuropsychiatric interview in which a number of basic questions are asked about fears and depression.)
FUNCTIONS OF THE CARDIOVASCULAR AND RESPIRATORY SYSTEMS
Functions of the cardiovascular system
Blood pressure (Using a DINAMAP, measurements during 10 minutes)
Electrical activity (12-lead electrocardiogram)
Functions of the respiratory system
Respiratory functions (Vital Capacity test (VC) and Forced expiratory volume (FEV1 ))
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Legend
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Administration environment
Hospital, clinic, university or recruitment center
Staff administering test
Professionals (nurses, clinicians, etc)
Interviewers/research assistants
Other
| Administration language | Dutch |
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Utilization conditions
SOPs are in Dutch, and describe generally accepted procedures
Standard operating procedures (SOPs) or reference information
| Name | DNA Processing |
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| Study name | LifeLines Cohort Study & Biobank [LifeLines] |
| Last update | 03/20/2009 |
Contact
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Bruce HR Wolffenbuttel (Scientific Director)
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University Medical Center Groningen
Groningen P.O. Box 30001 Phone: +31-50-3613962 Email: bwo@int.umcg.nl |
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Legend
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| Sample name | Blood | |
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| Main laboratory | ||
| Sample labels/traceability (% of samples) |
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| Pre-extraction sample storage format | Substrate storage condition |
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| DNA extraction | DNA extraction method |
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| Automation of handling |
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| DNA handling and storage | DNA diluent |
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| DNA concentration (ng/µl) | ||
| Storage conditions |
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| DNA quantification | Methods |
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| Technical quality |
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| DNA quality control | Percentage of samples that are tested | |
| DNA quality method |
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| DNA analysis | Platforms |
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| Technical quality |
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