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Alcohol and Bariatric Surgery (ABS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766322
Recruitment Status : Recruiting
First Posted : May 9, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Carle Foundation Hospital
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Brief 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.

Condition or disease Intervention/treatment
Obesity 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

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).

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Study Type : Observational
Estimated Enrollment : 112 participants
Observational Model: Other
Time Perspective: Other
Official Title: Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery
Study Start Date : March 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Gastric Bypass longitudinal
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
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.

Gastric Banding longitudinal
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
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.

Sleeve gastrectomy longitudinal
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
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.

Gastric Bypass (cross-sectional)
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
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.

Gastric Banding (cross-sectional)
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
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.

Sleeve gastrectomy (cross-sectional)
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
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.

Non-surgical group
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
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.




Primary Outcome Measures :
  1. Change from before bariatric surgery in the peak blood alcohol level and at approximately 9 months after bariatric surgery. [ Time Frame: 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. ]
    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.

  2. Change from before bariatric surgery in alcohol subjective effects at approximately 9 months after bariatric surgery [ Time Frame: 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. ]
    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.

  3. 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. [ Time Frame: 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. ]
    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.

  4. Change from before bariatric surgery in the rate of alcohol elimination and at approximately 9 months after bariatric surgery. [ Time Frame: 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 :
  1. Change from before bariatric surgery on alcohol's effects on glucose homeostasis at approximately 9 months after bariatric surgery. [ Time Frame: 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. ]

Biospecimen Retention:   Samples With DNA
Blood and Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bariatric surgery clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766322


Contacts
Layout table for location contacts
Contact: Belen Acevedo, PhD 2173004709 mba17@illinois.edu
Contact: Christine Canfield, BS, CCRP 2173260095 Christine.Canfield@Carle.com

Locations
Layout table for location information
United States, Illinois
University of Illinois at Urbana Champaign Recruiting
Urbana, Illinois, United States, 61801
Contact: Belen Acevedo, PhD    217-300-4709    mba17@illinois.edu   
Contact: Christine R Canfield, BS, CCRP    217-326-0095    Christine.Canfield@Carle.com   
Principal Investigator: Marta Y Pepino, PhD         
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Carle Foundation Hospital
Investigators
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Principal Investigator: Marta Y Pepino de Gruev, PhD UIUC

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02766322    
Other Study ID Numbers: 16135
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Illinois at Urbana-Champaign:
Alcohol metabolism
Bariatric surgery
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs