Trial document





This trial has been registered retrospectively.
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  DRKS00008742

Trial Description

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Title

Effects of repeated direct current stimulation on the systemic glucose tolerance

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

As previously shown, a single anodal tDCS modulates the human brain`s energy homeostasis, which, in turn, leads to improvements in systemic glucose tolerance in male participants. Therefore, the aim of the present study was to test experimentally if repetitive tDCS may persistently increase systemic glucose uptake in humans.

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Brief Summary in Scientific Language

One applied anodal direct current stimulation leads to improved systemic glucose tolerance. Still unknown is the effect of repetitive anodal direct current stimulation on glucose tolerance and cerebral energy homeostasis.

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Organizational Data

  •   DRKS00008742
  •   2016/02/25
  •   [---]*
  •   yes
  •   Approved
  •   11-152, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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

  •   Diabetes mellitus Typ 2
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Healthy, normal-weight subjects were twice 20 minutes anodal stimulated with a direct current stimulation (1 mA, fade in/ out 8 sec) during an euglycemic clamp within two hours. Periodically, the blood sugar levels, cerebral energy status and blood parameters are determined.
  •   Healthy, normal-weight subjects were sham stimulated twice during an euglycemic clamp within two hours. Periodically, the blood sugar levels, cerebral energy status and blood parameters are determined.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Glucose infusion rates, cerebral energy content is determined by imaging: Before the first transcranial direct current stimulation (baseline) and 10 measurement intervals of 10 minutes after each stimulation period

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Secondary Outcome

At 25 min intervals blood samples for hormonal analyses (cortisol, epinephrine, norepinephrine) were taken

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/01/02
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   25   Years
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Additional Inclusion Criteria

Healthy, no medication, regular sleep / wake rhythm, normal weight

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Exclusion Criteria

Body mass index > 25, females

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Addresses

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    • Sektion für PsychoneurobiologieUniversität Lübeck Frau Prof.Dr. Kerstin M. Oltmanns http://www.pnb.uni-luebeck.de
    • Ms.  Prof.  Kerstin M.  Oltmanns 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Sektion für PsychoneurobiologieUniversität Lübeck
    • Ms.  Ewelina Kinga  Wardzinski 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Sektion für PsychoneurobiologieUniversität Lübeck
    • Ms.  Ewelina Kinga  Wardzinski 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • 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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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/31
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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.