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

Bariatric Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380950
• Other study ID #: EKSG 13/046
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: March 2, 2015
• Start date: June 2013

Study information

• Verified date: March 2015
• Source: eSwiss Medical & Surgical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissethics
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Bariatric Surgery
• Cognitive Function

Intervention

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".

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
eSwiss Medical & Surgical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in reaction time after alcohol consumption		Change measures (baseline, 10 min, 45 min)	No