Trial document




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  DRKS00004363

Trial Description

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Title

Abnormalities of the formation of ethyl glucuronide in individuals with Gilbert's Disease or Crigler-Najjar-Syndrome.

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Trial Acronym

GMS-EtG

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URL of the Trial

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Brief Summary in Lay Language

Ethyl glucuronide is a metabolite of ethanol and ranks among the so called direct markers of ethanol consumption. It has high sensitivity and specificity for ethanol consumption. A limitation of sensitivity could result from a wide spread anomaly of metabolization (Gilbert's disease or Crigler-Najjar-Syndrome): Some individuals lack in the ability of glucuronidation. Glucuronidation means conjugation of glucuronid acid with substances for the reason of detoxification. This study is performed to test, whether individuals with these anomalies are able to form ethyl glucuronide. This is of importance for monitoring programs for abstinence, for example for regaining the driving licence.

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Brief Summary in Scientific Language

Ethyl glucuronide ranks among the direct ethanol consumption markers, resulting from the conjugation of ethanol and glucuronid acid. As direct metabolite, it has high sensitivity and specificity. Limitations of sensitivity could result from a wide spread anomaly with reduced function of UDP glucuronosyl transferase. This anomaly is known as Gilbert's disease and in a more distinct form as Crigler-Najjar-Syndrome. These anomalies have an incidence of 5 %. So far, there has not been tested, wheather the reduced function of the enzyme is connected with a non-detectability of ethyl glucuronide in urine. Since ethyl glucuronide is used to test for abstinence from ethanol, the knowlege of possible limitations is of great importance.

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Organizational Data

  •   DRKS00004363
  •   2012/09/14
  •   [---]*
  •   yes
  •   Approved
  •   303/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1134-6834 
  •   [---]* 
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Health Condition or Problem studied

  •   E80.5 -  Crigler-Najjar syndrome
  •   E80.4 -  Gilbert's syndrome
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Interventions/Observational Groups

  •   One-armed study
    After at least 2 days of abstinence from ethanol 100 test persons (50 men/women, if possible) are asked to drink 9 g of ethanol (0.1 l sparkling wine). This amount and drink was chosen to tie this experiment up to former data gained in a drinking experiment with healthy test persons without anomalies in metabolizing ethanol. After a void urine sample, the volunteers are asked to drink the sparkling wine. Urine samples should be collected after 3, 6, 12 and 24 hours. 3 hours after drinking, a blood sample will be taken. The urine samples are tested for EtG, the blood sample for EtG, bilirubine and hematologic and liver parameters.
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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
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Primary Outcome

Determination of ethyl glucuronide concentrations in the samples, interpretation of data in comparison to existing data from a former collective with no anomalies in metabolising.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/10/15
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Gilbert's Disease or Crigler-Najjar-Syndrome
- Age: 18+
- Good knowledge of spoken and written German
- Capacity to consent
- Two days of abstinence prior to the execution of the study

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Exclusion Criteria

- other liver diseases
- Diabetes mellitus
- Kidney diseases
- Cardio-vascular diseases
- known pregnancy

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Addresses

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    • Institut für Rechtsmedizin Forensische Pathologie
    • Ms.  PD Dr. med.   Annette  Thierauf 
    • Albertstraße 9
    • 79104  Freiburg
    • Germany
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    • Institut für Rechtsmedizin der Universität Freiburg
    • Ms.  PD Dr. med.   Annette  Thierauf 
    • Albertstraße 9
    • 79104  Freiburg
    • Germany
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    • Institut für Rechtsmedizin Forensische Toxikologie
    • Ms.  Laura  Huppertz 
    • Albertstraße 9
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bund gegen Alkohol und Drogen im Straßenverkehr e. V.
    • Arnold-Heise-Straße 26
    • 20249  Hamburg
    • Germany
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Status

  •   Recruiting planned
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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.