Trial document




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  DRKS00004229

Trial Description

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Title

Munich Diabetes Family Study

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Trial Acronym

MuDiF-Study

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URL of the Trial

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Brief Summary in Lay Language

Diabetes is one of the most common diseases affecting 7 to 8 million people (90 % attributable to type 2 diabetes) in Germany. The risk to develop type 2 diabetes (T2D) is specially high within families. This heterogenous metabolic disease results from a complex and poorly understood interaction between genetic factors and lifestyle components. To elucidate this relationship we aim to recruit families with healthy children and their diabetic parents and/or siblings . These families are medically charcterized and long-term monitored to study the onset and the progression of the disease. The ultimate goal is the development of novel therapeutic approaches for early detection and prevention.

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Brief Summary in Scientific Language

The current objective is the recruitment, characterization (geno-/phenotyping) and prospective monitoring of a novel diabetes family cohort to identify novel gene variants and to decipher the precise molecular mechanisms underlying the genetic associations to T2D. Based on this information, we are planning to develop novel approaches for early detection and prevention. The ultimate goal is the development of a genotype-dependent personalized prevention strategy in the field of T2D.

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Organizational Data

  •   DRKS00004229
  •   2012/09/04
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  •   yes
  •   Approved
  •   5404/12, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   TYP-2-DIABETES
  •   E11.9 -  Non-insulin-dependent diabetes mellitus; Without complications
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Interventions/Observational Groups

  •   All family members: physical investigation, body composition (bioimpedance analysis), fasting blood sampling, spontaneous Urine sample, faecal samples (optional), dietary record, physical activity measurement, questionnaires
    Additionally in healthy children: oral glucose tolerance test, ECG, facultative: adipose tissue biopsy, indirect calorimetry
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Characteristics

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

Characterization (geno-/phenotyping) of a cohort of families with type 2 diabetes.

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Secondary Outcome

- identification of potential new diagnostic biomarkers in a T2D risk cohort
- validation and cross-validation of newly detected biomarker signatures
- function of diabetes-related single nucleotid polymorphisms
- development and validation of specific dietary recommendations for disease prevention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2013/01/25
  •   1500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- type 2 diabetes families: at least two generations (parents, children); at least one parent with T2D; at least three participants per family (“trio”) with one disease-free index subject
- Caucasian origin
- no BMI restriction
- written informed consent

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Exclusion Criteria

- severe diseases, e.g. cancer, COPD, severe heart disease, progressive renal failure, severe psychiatric or neurological diseases
- type 1 diabetes, MODY or other rare types of diabetes
- drug or alcohol abuse
- continuous treatment with drugs influencing glucose tolerance, insulin sensitivity and/or insulin secretion
- continuous treatment with oral anticoagulants or antithrombotics (except ASS 100)
- gastrointestinal diseases impairing glucose absorption during oGTT
- insufficient language skills
- lack of written informed consent

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Addresses

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    • Else Kröner-fresenius-Zentrum für Ernährungsmedizin Klinikum rechts der Isar der TU München Uptown München Campus D
    • Prof. Dr. med.  Hans  Hauner 
    • Georg-Brauchle-Ring 62
    • 80992  München
    • Germany
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    • Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH
    • 85764  Neuherberg
    • Germany
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin Klinikum rechts der Isar der TU München Uptown München Campus D
    • Prof. Dr. med.  Hans  Hauner 
    • Georg-Brauchle-Ring 62
    • 80992  München
    • Germany
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Sources of Monetary or Material Support

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    • Technische Universität München Lehrstuhl für Ernährungsmedizin
    • 85350  Freising-Weihenstephan
    • Germany
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    • Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH
    • 85764  Neuherberg
    • Germany
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Status

  •   Recruiting stopped after recruiting started
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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.