Effects of Alcohol After Bariatric Surgery (RBA)

April 26, 2021 updated by: University of Illinois at Urbana-Champaign

Pharmacokinetics and Pharmacological Effects of Alcohol After Bariatric Surgery

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • University of Illinois at Urbana Champaign

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Bariatric surgery clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT01843257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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