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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

Study Description
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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.

Condition or disease Intervention/treatment
Obesity Other: Alcohol challenge test Alcohol visit first Other: Alcohol challenge test Placebo visit first

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Other
Official Title: Pharmacokinetics and Pharmacological Effects of Alcohol After Bariatric Surgery
Study Start Date : April 2013
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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).
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.
 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).
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.
 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).
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.
 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).
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.
 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).
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.
 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).
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.

 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  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.


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

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bariatric surgery clinic
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
Contacts and Locations
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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): NCT01843257


Contacts
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Contact: Maria B Acevedo, PhD 217-300-2374 mba17@illinois.edu
Contact: Marta Y Pepino, PhD 217-300-2374 ypepino@illinois.edu

Locations
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United States, Missouri
University of Illinois at Urbana Champaign Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Maria B Acevedo, PhD    217-300-2374    mba17@illinois.edu   
Contact: Marta Y Pepino, PhD    217-300-2374    ypepino@illinois.edu   
Principal Investigator: Marta Y Pepino, PhD         
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
University of Missouri-Columbia
Washington University School of Medicine
Investigators
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Principal Investigator: Marta Y Pepino, PhD University of Illinois at Urbana-Champaign
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01843257     History of Changes
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: October 2019
Keywords provided by University of Illinois at Urbana-Champaign:
Alcohol intake after bariatric surgery
Alcohol and 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