Trial document





This trial has been registered retrospectively.
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  DRKS00007713

Trial Description

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Title

European Study to Establish Biomarkers of Human Ageing

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Trial Acronym

MARK-AGE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The rate of ageing in humans is not uniform, due to genetic heterogeneity and the influence of environmental factors. Age-related changes in body function or composition that could serve as a measure of “biological” age and predict the onset of age-related diseases and/or residual lifetime are termed “biomarkers of ageing”. MARK-AGE identified a set biomarkers of ageing which, as a combination of parameters with appropriate weighting, would measure biological age better than any marker in isolation.

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Brief Summary in Scientific Language

The rate of ageing in humans is not uniform, due to genetic heterogeneity and the influence of environmental factors. Age-related changes in body function or composition that could serve as a measure of “biological” age and predict the onset of age-related diseases and/or residual lifetime are termed “biomarkers of ageing”. Many candidate biomarkers have been proposed but in all cases their variability in cross-sectional studies is considerable, and therefore no single measurement has so far proven to yield a useful biomarker of ageing on its own, probably due to the multi-causal and multi-system nature of ageing. In MARK-AGE project a population study (3,300 probands) was conducted in order to identify a set biomarkers of ageing which, as a combination of parameters with appropriate weighting, would measure biological age better than any marker in isolation. A wide range of candidate biomarkers have been tested, including (a) “classical” ones for which data from several smaller studies have been published; (b) “new” ones, based on recent preliminary data, as well as (c) “novel” ones, based on recent research on mechanistic aspects of ageing, conducted by project participants. Bioinformatics were used in order to extract a robust set of biomarkers of human ageing from the large amounts of data to be generated and to derive a model for healthy ageing.

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Organizational Data

  •   DRKS00007713
  •   2015/03/18
  •   [---]*
  •   yes
  •   Approved
  •   2008-075-f, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1166-3444 
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Health Condition or Problem studied

  •   Aging
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Interventions/Observational Groups

  •   (A) Randomly recruited age-stratified individuals from the general population covering the age range 35-74 years; (B) subjects born from a long-living parent belonging to a family with long living sibling(s) already recruited in the framework of the GEHA project. For genetic reasons such individuals (“GEHA offspring”) are expected to age at a slower rate. They have been recruited together with (C) their spouses as controls. (D) A small number of patients with progeroid syndromes have also been included in the study.
    From all subjects enrolled, anthropometric, clinical and social data were collected (demographic information, lifestyle, functional status, cognitive status, health status, mood). Also a physical examination (body mass index, waist and hip circumference, blood pressure at rest, heart rate at rest, lung capacity, near vision, five-times chair standing, handgrip strength) was performed.
    All subjects were asked to donate blood (50 ml) after overnight fasting. The blood samples were processed to obtain plasma, serum, peripheral blood monouclear cells (PBMC). Buccal mucosal cells and spot urine samples were also collected.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

MARK-AGE aims the identification of powerful biomarkers of human ageing across a range of physiological systems

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Secondary Outcome

Recruitment of probands enables, in the first place, a cross-sectional approach to develop biomarkers of ageing. However, within the lifetime of the project (60 months), a limited random sample of probands will be re-tested in order to establish a longitudinal component within the study.

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Countries of Recruitment

  •   Belgium
  •   Italy
  •   Netherlands
  •   Poland
  •   Germany
  •   Finland
  •   Greece
  •   Austria
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2008/11/03
  •   3300
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   74   Years
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Additional Inclusion Criteria

Randomly recruited age-stratified individuals from the general population (both sexes) aged 35-74, who signed informed consent. Son or daughter of GEHA 90+ siblings, and their spouses; probands must be aged 55-74 who signed informed consent. Subjects affected by Down syndrome (DS), WS (Werner syndrome) and Cockayne syndrome (CS) that signed informed consent through their responsible family member or caregivers.

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Exclusion Criteria

Subjects with any of the following characteristics were excluded from the study: [1] self reported seropositivity for HIV, HBV (except seropositivity by vaccination) and HCV; [2] seropositivity for HBV or HCV assessed after blood collection; [3] current cancer treatment or administration of glucocorticoids; [4] less than 50% of lifetime spent in country of residence; [5] inability to give informed consent. N.B. In the case of acute illness within the 7 days preceding the scheduled appointment.

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Addresses

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    • European Commission Directorate-General for Research and Innovation Health Research
    • Ms. 
    • 200, Rue de la Loi
    • 1049  Brussels
    • Belgium
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    • Universität Konstanz
    • Mr.  Professor  Alexander  Bürkle 
    • 628
    • 78457  Konstanz
    • Germany
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    • Universität Konstanz
    • Mr.  Professor  Alexander  Buerkle 
    • Univesitätstrasse 10
    • 78464  Konstanz
    • Germany
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Sources of Monetary or Material Support

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    • European CommissionDirectorate-General for Research and InnovationHealth ResearchUnit E4 - Medical research and the challenge of ageing
    • Ms.  Dr  Beatrice  Lucaroni 
    • 200, Rue de la Loi
    • 1049  Brussels
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.