Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00020593

Trial Description

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Title

European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam

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Trial Acronym

EPIC-Potsdam

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URL of the Trial

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Brief Summary in Lay Language

EPIC-Potsdam is a population-based unselected longitudinal cohort study from Potsdam, Germany, and is part of the international multicenter European Prospective Investigation into Cancer and Nutrition (EPIC) cohort - one of the largest cohort studies with overall approximately 475,000 study participants, on the etiological influence of diet on the development and progression of chronic diseases, such as type 2 diabetes, cardiovascular diseases or cancer.

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Brief Summary in Scientific Language

At baseline, EPIC-Potsdam recruited about 27,500 men and women from 1994 to 1998. The recruitment process of EPIC-Potsdam was based on addresses from general population registries in the municipality of Potsdam, Germany. Baseline assessments comprised anthropometric measures, blood pressure measurement and blood sampling by qualified medical personnel. Lifestyle, sociodemographic characteristics, and current health status were assessed with validated questionnaires and in face-to-face interviews. Participants are followed up every 2-3 years via questionnaires regarding incident diseases (cancer, diabetes, colitis, stroke, myocardial infarction, heart failure, hypertension), all-cause mortality, dietary patterns, physical activity status, life style and anthropometric measures. Response rates range between 90-96% per follow up period.
The study complies to the principles of the 2nd Declaration of Helsinki. And was approved by the Ethics Committee of the State of Brandenburg.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00020593
  •   2020/03/02
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  •   yes
  •   Approved
  •   AS 29/93, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   E11 -  Type 2 diabetes mellitus
  •   I21 -  Acute myocardial infarction
  •   I63 -  Cerebral infarction
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Prospective investigation of dietary and lifestyle factors and incidence of type 2 diabetes, cancer and other chronic diseases.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Primary outcomes: type 2 diabetes, cancer, cardiovascular disease, collitis, stroke, myocardial infarction, heart failure, hypertension.
Sources of information: self-report of a respective diagnosis, pharmacological treatment or dietary change due to disease collected through follow-up questionnaires which were sent every 2–3 years by mail. Further sources of information included death certificates, tumor centers, clinical records linkage. Verification of potential cases was carried out through standardized forms filled by the participants’ treating physicians.

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Secondary Outcome

Secondary endpoints: diabetes-associated complications (nephropathy, retinopathy, neuropathy).
Information sources are: self-report of appropriate diagnosis or pharmacological treatment. The verification of potential cases was performed in 2014 by standardized questionnaires filled out by the attending physicians of the participants.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   1994/08/01
  •   30000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Men and women 35-64 years of age

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Exclusion Criteria

missing informed consent

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Addresses

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    • German Institute of Human Nutrition Department of Molecular Epidemiology
    • Arthur-Scheunert-Allee 114-116
    • 14558  Nuthetal
    • Germany
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    • German Institute of Human Nutrition Department of Molecular Epidemiology
    • Mr.  Prof.  Matthias  Schulze 
    • Arthur-Scheunert-Allee 114-116
    • 14558  Nuthetal
    • Germany
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    • German Institute of Human Nutrition Department of Molecular Epidemiology
    • Mr.  Prof.  Matthias  Schulze 
    • Arthur-Scheunert-Allee 114-116
    • 14558  Nuthetal
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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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 continuing
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Trial Publications, Results and other Documents

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