Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : April 27, 2021
Sponsor:
Collaborator:
Carle Foundation Hospital
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Tracking Information
First Submitted Date April 27, 2016
First Posted Date May 9, 2016
Last Update Posted Date April 27, 2021
Study Start Date March 2016
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2016)
  • 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.
  • 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.
  • 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.
  • 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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 15, 2018)
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. ]
Original Secondary Outcome Measures
 (submitted: May 5, 2016)
  • 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. ]
  • Change from before bariatric surgery on alcohol's effect on fitness to drive compared to 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. ]
    A driving simulator will be used at 3 time points during each visit to measure subjects' fitness to drive before bariatric surgery compared with their fitness to drive post- bariatric surgery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alcohol and Bariatric Surgery
Official Title Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery
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.
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).
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and Plasma
Sampling Method Non-Probability Sample
Study Population Bariatric surgery clinic
Condition Obesity
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
  • 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..
    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 5, 2016)
112
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years to 64 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Neda Seyedsadjadi, PhD 2173004709 nedase@illinois.edu
Contact: Christine Canfield, BS, CCRP 2173260095 Christine.Canfield@Carle.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02766322
Other Study ID Numbers 16135
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Illinois at Urbana-Champaign
Study Sponsor University of Illinois at Urbana-Champaign
Collaborators Carle Foundation Hospital
Investigators
Principal Investigator: Marta Y Pepino de Gruev, PhD UIUC
PRS Account University of Illinois at Urbana-Champaign
Verification Date April 2021