NCT02766322

Alcohol and Bariatric Surgery

Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: University of Illinois at Urbana-Champaign · Academic / Other
• Sex: Female
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The investigators wish to study the effects of alcohol on three forms of bariatric surgery, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and laparoscopic adjustable gastric banding (LAGB) and compare them with a non-surgical group. The surgery is not part of the clinical trial. If insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body, 2) the effects of alcohol on mood, and 3) the effects of alcohol on driving.

Detailed description

The study includes seven groups of women: One group will be undergoing RYGB another group will be undergoing LAGB, a third group will be undergoing SG, the fourth group will be women who underwent RYGB 1-5 years ago, the fifth group will be women who underwent LAGB 1-5 years ago, the sixth group will be women who underwent SG 1-5 years ago and the seventh group will be women who have equivalent age and body mass index than women in the groups who underwent RYGB or SG 1-5 years ago but did not have bariatric surgery (non-surgical group).

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	Oral Alcohol challenge test Alcohol visit first	Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
OTHER	Oral Alcohol challenge test Placebo visit first	Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
OTHER	Intravenous Alcohol Challenge Test (Clamp)	Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
OTHER	Intravenous Alcohol Self-administration Test	Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.

Timeline

• Start date: 2016-03-01
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2016-05-09
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States