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

NCT ID: NCT02380950

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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".

Detailed Description

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Conditions

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Bariatric Surgery Alcohol Consumption Cognitive Function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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".

Group Type OTHER

250 ml alcohol consumption

Intervention Type BEHAVIORAL

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".

Interventions

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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".

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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eSwiss Medical & Surgical Center

OTHER

Sponsor Role lead

Responsible Party

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Bernd Schultes

Prof. Dr. med. Bernd Schultes

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EKSG 13/046

Identifier Type: -

Identifier Source: org_study_id

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