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Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass

Primary Purpose

Bariatric Surgery, Alcohol Consumption, Cognitive Function

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
250 ml alcohol consumption
Sponsored by
eSwiss Medical & Surgical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bariatric Surgery

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Gastric bypass group:

  • women
  • preOP BMI >35 kg/m²
  • time since bariatric surgery > 1 year
  • age 18-60 years
  • moderate drinking habits

obese group:

  • women
  • BMI >35 kg/m²
  • age 18-60 years
  • moderate drinking habits

normal weight group:

  • women
  • BMI 18.5 - 25 kg/m²
  • age 18-60 years
  • moderate drinking habits

Exclusion Criteria:

  • men
  • patient does not drink wine
  • usage of psychotropic drugs
  • alcoholic
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    250 ml alcohol consumption

    Arm Description

    Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".

    Outcomes

    Primary Outcome Measures

    Change in reaction time after alcohol consumption

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2015
    Last Updated
    March 2, 2015
    Sponsor
    eSwiss Medical & Surgical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02380950
    Brief Title
    Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    eSwiss Medical & Surgical Center

    4. Oversight

    5. Study Description

    Brief Summary
    Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol effects after gastric bypass we suggest that also general cognitive function is stronger impaired. Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8 normal weight subjects) in the study. Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bariatric Surgery, Alcohol Consumption, Cognitive Function

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    250 ml alcohol consumption
    Arm Type
    Other
    Arm Description
    Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".
    Intervention Type
    Behavioral
    Intervention Name(s)
    250 ml alcohol consumption
    Intervention Description
    Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".
    Primary Outcome Measure Information:
    Title
    Change in reaction time after alcohol consumption
    Time Frame
    Change measures (baseline, 10 min, 45 min)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Gastric bypass group: women preOP BMI >35 kg/m² time since bariatric surgery > 1 year age 18-60 years moderate drinking habits obese group: women BMI >35 kg/m² age 18-60 years moderate drinking habits normal weight group: women BMI 18.5 - 25 kg/m² age 18-60 years moderate drinking habits Exclusion Criteria: men patient does not drink wine usage of psychotropic drugs alcoholic pregnancy

    12. IPD Sharing Statement

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    Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass

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