Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass
1 other identifier
interventional
28
0 countries
N/A
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedMarch 5, 2015
March 1, 2015
3 months
February 19, 2015
March 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in reaction time after alcohol consumption
Change measures (baseline, 10 min, 45 min)
Study Arms (1)
250 ml alcohol consumption
OTHEREach 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
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".
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- men
- patient does not drink wine
- usage of psychotropic drugs
- alcoholic
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Bernd Schultes
Study Record Dates
First Submitted
February 19, 2015
First Posted
March 5, 2015
Study Start
June 1, 2013
Primary Completion
September 1, 2013
Last Updated
March 5, 2015
Record last verified: 2015-03