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

Sponsor
eSwiss Medical & Surgical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02380950
Collaborator
(none)
28
Enrollment
1
Arm

Study Details

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".

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 250 ml alcohol consumption
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Sep 1, 2013

Arms and Interventions

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".

Outcome Measures

Primary Outcome Measures

  1. Change in reaction time after alcohol consumption [Change measures (baseline, 10 min, 45 min)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • eSwiss Medical & Surgical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bernd Schultes, Prof. Dr. med. Bernd Schultes, eSwiss Medical & Surgical Center
ClinicalTrials.gov Identifier:
NCT02380950
Other Study ID Numbers:
  • EKSG 13/046
First Posted:
Mar 5, 2015
Last Update Posted:
Mar 5, 2015
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms:
Alcohol Drinking

Study Results

No Results Posted as of Mar 5, 2015