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

March 2, 2015 updated by: Bernd Schultes, eSwiss Medical & Surgical Center

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 250 ml alcohol consumption
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".
Behavioral: 250 ml alcohol consumption
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in reaction time after alcohol consumption
Time Frame: Change measures (baseline, 10 min, 45 min)
Change measures (baseline, 10 min, 45 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

eSwiss Medical & Surgical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKSG 13/046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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