Trial document





This trial has been registered retrospectively.
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  DRKS00009277

Trial Description

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Title

Berlin Aging Study II - Medical Part

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Trial Acronym

BASE-II

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URL of the Trial

https://www.base2.mpg.de/en

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Brief Summary in Lay Language

As in other countries, life expectancy in Germany is rising. The researchers of the Berlin Aging Study II (BASE-II) investigate how these additional years can be lived healthily and actively. The Berlin Aging Study II is an extension and expansion of the longitudinal Berlin Aging Study (BASE). In 1990–1993, this interdisciplinary study initially examined 516 men and women of the western part of Berlin aged between 70 and 100 and has continuously followed them up to the present.
The continuation study BASE-II investigates the physical, cognitive, and social conditions that lead to successful aging. Repetition of the assessments is in planning to gain information about aging over time.

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Brief Summary in Scientific Language

The Berlin Aging Study II is a multi-disciplinary project with several research units. The medical part of BASE-II is planning a series of analyses including the relationship between medical factors and ‘healthy’ vs. ‘unhealthy’ aging. Among the topics the medical part of the study is interested in: sarcopenia, frailty, body composition, cardiovascular diseases, type 2 diabetes, metabolic syndrome, lipid metabolism, telomere biology, nutrition

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Organizational Data

  •   DRKS00009277
  •   2015/08/31
  •   [---]*
  •   yes
  •   Approved
  •   EA2/029/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   assessment of objective health, age-related diseases
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Interventions/Observational Groups

  •   BASE-II is a convinience sample of younger participants (20-35 years) and older participants (60-80 years).
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Characteristics

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

objective health:
cardiovascular system, metabolic disorders, diseases of the musculosceletal system; among the collected variables: anamnestic medical data, anthropometric data, nutritional assessment (frequency food questionnaire, minimal nutritional assessment), Rapid assessment of physical activity, blood parameters, functional tests: 2h-ECG, blood pressure, pulse wave velocity, DXA, bioimpedance analysis, geriatric assessment, grip strength.
Assessments were performed continously between 2009 and 2014.
For an overview of the assessments/instruments see Bertram et al., 2014

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Secondary Outcome

subjective health (questionnaire),
quality of life (questionnaire SF-36),
sexual life (questionnaire),
drug use/ medication of the last 3 and 12 months (questionnaire),
leukocyte telomere length (RT-PCR),
lifestyle factors questionnaires (consumption of alcohol, cigarettes, drugs),
Barthel index,
sleeping quality (Pittsburgh sleep quality index - PSQI)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/06/17
  •   2200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   80   Years
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Additional Inclusion Criteria

Age between 60 and 80 years or age between 20-35 years. Residents of the greater metropolitan area of
Berlin, Germany. Written informed consent.

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Exclusion Criteria

Age not between 20-35 or 60-80 years. Not resident of the greater metropolitan area of Berlin, Germany.

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Addresses

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    • Charité - Universitätsmedizin Berlin
    • Ms.  Prof.  Elisabeth  Steinhagen-Thiessen 
    • 13347  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Charité - Universitätsmedizin Berlin
    • Mr.  PD Dr.  Ilja  Demuth 
    • Reinickendorfer Str. 61
    • 13347  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  PD Dr.  Ilja  Demuth 
    • Reinickendorfer Str. 61
    • 13347  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/31
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Trial Publications, Results and other Documents

  •   Cohort profile: The Berlin Aging Study II (BASE-II). Bertram L, Böckenhoff A, Demuth I, Düzel S, Eckardt R, Li SC, Lindenberger U, Pawelec G, Siedler T, Wagner GG, Steinhagen-Thiessen E.. Int J Epidemiol. 2014 Jun;43(3):703-12
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* This entry means the parameter is not applicable or has not been set.