Alcohol and Bariatric Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Other: Oral Alcohol challenge test Alcohol visit first
* Other: Oral Alcohol challenge test Placebo visit first
* Other: Intravenous Alcohol Challenge Test (Clamp)
* Other: Intravenous Alcohol Self-administration Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Drink at least 1 standard alcoholic beverage/ month Underwent RYGB, SG, or LAGB 1-5 years ago or will undergo RYGB, SG, or LAGB surgery Did not undergo bariatric surgery (for the non-surgical group) Exclusion Criteria: Male Smoker or quit < 6 months ago Anemia Liver disease Body weight > 450 pounds Taking medications that can interact with alcohol metabolism or the subjective effects of alcohol

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric Bypass longitudinal<br>Morbidly obese subjects undergoing gastric bypass surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose   16% of their presurgery body weight. | Other: Oral Alcohol challenge test Alcohol visit first<br>* 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).<br>Other: Oral Alcohol challenge test Placebo visit first<br>* 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).<br>Other: Intravenous Alcohol Challenge Test (Clamp)<br>* 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.<br>Other: Intravenous Alcohol Self-administration Test<br>* 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.<br>|
| Gastric Banding longitudinal<br>Morbidly obese subjects undergoing laparoscopic gastric banding surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose   16% of their presurgery body weight. | Other: Oral Alcohol challenge test Alcohol visit first<br>* 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).<br>Other: Oral Alcohol challenge test Placebo visit first<br>* 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).<br>Other: Intravenous Alcohol Challenge Test (Clamp)<br>* 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.<br>Other: Intravenous Alcohol Self-administration Test<br>* 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.<br>|
| Sleeve gastrectomy longitudinal<br>Morbidly obese subjects undergoing sleeve gastrectomy surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose   16% of their presurgery body weight.. | Other: Oral Alcohol challenge test Alcohol visit first<br>* 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).<br>Other: Oral Alcohol challenge test Placebo visit first<br>* 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).<br>Other: Intravenous Alcohol Challenge Test (Clamp)<br>* 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.<br>Other: Intravenous Alcohol Self-administration Test<br>* 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.<br>|
| Gastric Bypass (cross-sectional)<br>Subjects who underwent gastric bypass surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. | Other: Oral Alcohol challenge test Alcohol visit first<br>* 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).<br>Other: Oral Alcohol challenge test Placebo visit first<br>* 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).<br>Other: Intravenous Alcohol Challenge Test (Clamp)<br>* 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.<br>Other: Intravenous Alcohol Self-administration Test<br>* 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.<br>|
| Gastric Banding (cross-sectional)<br>Subjects who underwent gastric banding surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. | Other: Oral Alcohol challenge test Alcohol visit first<br>* 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).<br>Other: Oral Alcohol challenge test Placebo visit first<br>* 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).<br>Other: Intravenous Alcohol Challenge Test (Clamp)<br>* 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.<br>Other: Intravenous Alcohol Self-administration Test<br>* 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.<br>|
| Sleeve gastrectomy (cross-sectional)<br>Subjects who underwent sleeve gastrectomy surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. | Other: Oral Alcohol challenge test Alcohol visit first<br>* 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).<br>Other: Oral Alcohol challenge test Placebo visit first<br>* 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).<br>Other: Intravenous Alcohol Challenge Test (Clamp)<br>* 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.<br>Other: Intravenous Alcohol Self-administration Test<br>* 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.<br>|
| Non-surgical group<br>Subjects who are age and body mass index equivalent to gastric bypass (cross-sectional) and Sleeve gastrectomy (cross-sectional) but did not undergo any type of bariatric surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. | Other: Oral Alcohol challenge test Alcohol visit first<br>* 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).<br>Other: Oral Alcohol challenge test Placebo visit first<br>* 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).<br>Other: Intravenous Alcohol Challenge Test (Clamp)<br>* 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.<br>Other: Intravenous Alcohol Self-administration Test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from before bariatric surgery in the peak blood alcohol level and at approximately 9 months after bariatric surgery. | Time to reach maximum peak blood alcohol levels will be examined before and after surgery and compared between those who had gastric bypass or gastric sleeve versus lap banding and the non surgery control group. | Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only. | 
| Change from before bariatric surgery in alcohol subjective effects at approximately 9 months after bariatric surgery | Validated instruments (such as the Addiction Research Center Inventory) will be used to measured alcohol's subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage as well as receiving intravenous alcohol or intravenous saline solution. | Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only. | 
| Change from before bariatric surgery in the area under the curve for blood alcohol concentration (BAC) versus time and at approximately 9 months after bariatric surgery. | The area under the curve for BAC will be examined before and after surgery. and compared between those who had gastric bypass or gastric sleeve versus lap banding and the non surgery control group. | Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only. | 
| Change from before bariatric surgery in the rate of alcohol elimination and at approximately 9 months after bariatric surgery. |  | Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from before bariatric surgery on alcohol's effects on glucose homeostasis at approximately 9 months after bariatric surgery. |  | Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol metabolism, Bariatric surgery