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Effects of Alcohol After Bariatric Surgery (RBA)

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ClinicalTrials.gov Identifier: NCT01843257
Recruitment Status : Recruiting
First Posted : April 30, 2013
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
University of Missouri-Columbia
Washington University School of Medicine
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Tracking Information
First Submitted Date April 22, 2013
First Posted Date April 30, 2013
Last Update Posted Date November 13, 2019
Study Start Date April 2013
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2015)
  • Change from before bariatric surgery in alcohol's Tmax, Cmax, area under the curve and elimination rates 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, alcohol area under the time-concentration curve and alcohol's constant of elimination will be examined before and after surgery and compared between those who had gastric bypass versus lap banding.
  • 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.
Original Primary Outcome Measures
 (submitted: April 25, 2013)
  • Change from before bariatric surgery in alcohol's Tmax, Cmax, AUC and elimination rates 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, alcohol area under the time-concentration curve and alcohol's constant of elimination will be examined before and after surgery and compared between those who had gastric bypass versus lap banding.
  • Change from before bariatric surgery in alcohol stimulant and sedative 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 alcohol biphasic effects scale) will be used to measured alcohol's stimulant and sedative effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage.
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2013)		 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 Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Alcohol After Bariatric Surgery
Official Title Pharmacokinetics and Pharmacological Effects of Alcohol After Bariatric Surgery
Brief Summary The investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. 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 blood sugar; and 3) the effects of alcohol on mood.
Detailed Description The study includes seven groups of women: One group will be undergoing gastric bypass, another group will be undergoing lap banding, a third group will be undergoing sleeve gastrectomy, the fourth group will be women who underwent gastric bypass 1-5 years ago, the fifth group will be women who underwent lap banding 1-5 years ago, the sixth group will be women who underwent sleeve gastrectomy 1-5 years ago, and the seventh group will be a control group who have not undergone bariatric surgery.
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: 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: 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).
Study Groups/Cohorts
  • Gastric Bypass longitudinal
    Morbidly obese subjects undergoing gastric bypass surgery. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery.
    Interventions:
    • Other: Alcohol challenge test Alcohol visit first
    • Other: Alcohol challenge test Placebo visit first
  • Gastric Banding longitudinal
    Morbidly obese subjects undergoing laparoscopic gastric banding surgery. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery.
    Interventions:
    • Other: Alcohol challenge test Alcohol visit first
    • Other: Alcohol challenge test Placebo visit first
  • Gastric Bypass (cross-sectional)
    Subjects who underwent gastric bypass surgery 1-5 years ago. 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 before surgery.
    Interventions:
    • Other: Alcohol challenge test Alcohol visit first
    • Other: Alcohol challenge test Placebo visit first
  • Gastric Banding (cross-sectional)
    Subjects who underwent gastric banding surgery 1-5 years ago. 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 before surgery.
    Interventions:
    • Other: Alcohol challenge test Alcohol visit first
    • Other: Alcohol challenge test Placebo visit first
  • Sleeve gastrectomy (longitudinal)
    Morbidly obese subjects who will undergo sleeve gastrectomy. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery.
    Interventions:
    • Other: Alcohol challenge test Alcohol visit first
    • Other: Alcohol challenge test Placebo visit first
  • Sleeve gastrectomy (cross-sectional)
    Subjects who underwent sleeve gastrectomy 1-5 years ago. 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 before surgery.
    Interventions:
    • Other: Alcohol challenge test Alcohol visit first
    • Other: Alcohol challenge test Placebo visit first
  • No bariatric surgery control

    Control group of women with age and BMI similar to those in the cross-sectional arm of the study who have not undergone bariatric surgery.

    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 before surgery.

    Interventions:
    • Other: Alcohol challenge test Alcohol visit first
    • Other: Alcohol challenge test Placebo visit first
Publications * Pepino MY, Okunade AL, Eagon JC, Bartholow BD, Bucholz K, Klein S. Effect of Roux-en-Y Gastric Bypass Surgery: Converting 2 Alcoholic Drinks to 4. JAMA Surg. 2015 Nov;150(11):1096-8. doi: 10.1001/jamasurg.2015.1884.

*   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: January 23, 2017)		 100
Original Estimated Enrollment
 (submitted: April 25, 2013)		 48
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women
  • Drink alcohol at least once per month

Exclusion Criteria:

  • Men
  • Drinks more than 7 standard drinks per week or more than 4 standard drinks in a period of 2 hours for the month before enrolling in the study.
  • Regular use of drugs of abuse or use of any medication interacting with alcohol pharmacokinetics or pharmacologic effects.
  • Alcohol dependence
  • Pregnancy, lactation or not using effective methods of birth control
  • Smoking
  • Anemia
  • Liver disease
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Maria B Acevedo, PhD 217-300-2374 mba17@illinois.edu
Contact: Marta Y Pepino, PhD 217-300-2374 ypepino@illinois.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01843257
Other Study ID Numbers Not Provided
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Illinois at Urbana-Champaign
Study Sponsor University of Illinois at Urbana-Champaign
Collaborators
  • University of Missouri-Columbia
  • Washington University School of Medicine
Investigators
Principal Investigator: Marta Y Pepino, PhD University of Illinois at Urbana-Champaign
PRS Account University of Illinois at Urbana-Champaign
Verification Date October 2019