Trial document





This trial has been registered retrospectively.
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  DRKS00005070

Trial Description

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Title

Translational examinations of the role of B-Lymphozyte stimulator (BLyS) in the pathophysiology of type 2 diabetes in humans

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of the present study ist to examine if a weight reduction excerts beneficial effects on inflammatory factors. Therefore blood samples will be taken form obese human subjects who undergo a 12 weeks 800-kcal/d Formuladiet before, during (4 weeks) and after (12 weeks) the dietary intervention an the inflammatory factor BLyS will be measured. It is planed to include a total amount of 75 patients.

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Brief Summary in Scientific Language

It is assumed that prevalence of type 2 diabetes will increase to a total number 380 million in 2025 worldwide. Especially the associated risk for the development of cardiovascular diseases will yield medical and socio-economic problems. However, not every obese patient develops a type 2 diabetes, which resulted in the definition of so called "healthy obese" and "metabolically affected obese" human subjects. In the metabolically affected individuals the number of macrophages in adipose tissue is increased. This so called low-grade inflammation is thought to be the cause for many of the cardiovascular abnormalities found in type 2 diabetes. In adipose tissue, the recruitment of macrophages is regulated e. g. by B-lymphocytes. The B-Lymphocytes are thought to be activated by the factor BLyS, which in animal models has been shown to be released from adipocytes. BLyS belongs to the TNF ligand superfamily and is also called BAFF, TALL-1 and TNFSF13B. BLyS has been shown in animal models to be a factor potentially linking metabolism and inflammation. The aim of the present study is to examine, if BLyS also in humans is a major contributor to type 2 diabetes and its complications.

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Organizational Data

  •   DRKS00005070
  •   2013/06/14
  •   [---]*
  •   yes
  •   Approved
  •   D474/11, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   E66.9 -  Obesity, unspecified
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Interventions/Observational Groups

  •   weight reduction using a very-low-calorie-diet (VLCD). That means 800 kcal/d for 12 weeks. Laboratory testing at day 0 and week 4 and 12. During the study only blood smaples are to be taken (e. g. no additional questionairs)
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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

Changes in BLyS erum levels between day 0 and weeks 4 and 12.

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Secondary Outcome

Changes in body weight between day 0 and weeks 4 and 12.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/01
  •   75
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. obesity and/or type 2 diabetes
2. informed consent
3. men and women, 18-80 years of age
4. caucasian descent

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Exclusion Criteria

1. lipodystrophy
2. oncological disease
3. LFT >3-fold of normal range
4. creatinin > 1.5 mg/dl
5. Hyper- or hypotcortisolism
6. Hyper- or hypothyreosis
7. known HIV, HBV oder HCV infektion

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Addresses

  • start of 1:1-Block address primary-sponsor
    • UKSH, Campus Kiel Klinik für Innere Medizin 1
    • Mr.  Prof. Dr.  Matthias  Laudes 
    • Arnold Heller Strasse 3
    • 24105  Kiel
    • Germany
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    • UKSH, Campus Kiel Klinik für Innere Medizin 1
    • Mr.  Prof. Dr.  Matthias  Laudes 
    • Arnold Heller Strasse 3
    • 24105  Kiel
    • Germany
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    • UKSH, Campus Kiel Klinik für Innere Medizin 1
    • Mr.  Prof. Dr.  Matthias  Laudes 
    • Arnold Heller Strasse 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • deutsche diabetes stiftung
    • Mr.  Prof. Dr.  Rüdiger  Landgraf 
    • Staffelstrasse 6
    • 81477  München
    • Germany
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Status

  •   Recruiting ongoing
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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.