Alcohol After Bariatric Surgery 2 (ABS2)

September 2, 2026 updated by: University of Illinois at Urbana-Champaign

Pharmacokinetics and Responses to Alcohol After Bariatric Surgery

The goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy. The main question[s]it aims to answer are:

  • Are there differences in the way that ingested alcohol is handled in men versus women after sleeve gastrectomy?
  • What is the consequence of drinking alcohol on an empty stomach versus after a meal on blood sugar control after undergoing sleeve gastrectomy?

Participants will participate in two types of alcohol tests (alcohol given orally or administered intravenously) after not eating anything overnight or after having a meal.

Researchers will compare men and women who underwent sleeve gastrectomy with men and women who had no surgery, are of similar age and body composition, and have similar alcohol intake patterns.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary goal of the proposed study is to determine sex-related differences in the impact of Sleeve Gastrectomy (SG) on the pharmacokinetics (Aim 1), subjective effects (Aim 2), and glycemic effects (Aim 3) in the fasted versus prandial state when alcohol is ingested or given intravenously clamped (the gold standard to measure alcohol elimination rate and acute alcohol tolerance). We will use a cross-sectional study to compare participants who underwent SG surgery 1-5 years ago with matched non-operated controls (both sexes). This project will answer the questions of whether there are sex-related differences in the impact of SG on alcohol's pharmacokinetics and pharmacologic effects, whether drinking alcohol with a meal is effective post-SG, and clarify the site of alcohol first-pass metabolism in men. Findings from this study will contribute to evidence-based recommendations on the impact of SG on alcohol-related toxic effects and could help expand the knowledge base of sex-related differences in human alcohol pharmacokinetics.

Study Type

Observational

Enrollment (Estimated)

88

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • University of Illinois at Urbana Champaign
        • Contact:
        • Principal Investigator:
          • Marta Y Pepino, PhD

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Carle Foundation Hospital and community sample

Description

Inclusion Criteria:

  • Surgery groups:

    • Male and female, 21-64 yrs. of age
    • Drink at least 1 standard drink per month but no more than 7 per week (women or > 14 for men)
    • Underwent SG surgery 1-5 years ago

Non-surgery control group

  • Male and female who did not undergo bariatric surgery
  • Age , BMI, race , and alcohol pattern of consumption equivalent to participants in the SG surgery groups

Exclusion Criteria:

  • For all groups (surgery and non-surgery groups)

    • Smoking or having quit smoking less than 2 months ago
    • Pregnant or breastfeeding
    • Taking any medications that might affect alcohol metabolism
    • Anemia
    • Gastritis, colitis, Crohn's Disease, malabsorptive diseases, inflammatory diseases, liver disease, kidney disease, cancer less than five years ago, stroke, or severe organ dysfunction
    • Body weight >450 pounds (because of a limit on body composition machine)
    • Alcohol use disorder
    • Regular use of drugs with addiction potential or regular misuse of substances
    • Abnormality on EKG as determined by a study physician to present a safety risk

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
Women 1-5 years post-SG
  • Alcohol orally administered (0.5 grams per kg of Fat-free mass) after overnight fast or after a standard meal
  • Alcohol administered IV using an alcohol clamp (target concentration of 0.6g/L after an overnight fast or one hour after consuming a standard mixed meal)
Drug: Alcohol (Ethanol)
Alcohol given orally (0.5 grams of alcohol per kg of fat-free mass) Alcohol given iv with a clamp ( 6% v/v alcohol prepared in 0.5% normal saline). The infusion rate will exponentially increase from the start of the infusion until the target BrAC of 0.6g/L (60mg%) is reached at 15 min, followed by an exponentially decreasing infusion rate, which will be tapered to a constant steady-state value to clamp the BrAC at the target value for a predetermined duration of 180 min.
Men 1-5 years post-SG
  • Alcohol orally administered (0.5 grams per kg of Fat-free mass) after overnight fast or after a standard meal
  • Alcohol administered IV using an alcohol clamp (target concentration of 0.6g/L after an overnight fast or one hour after consuming a standard mixed meal)
Drug: Alcohol (Ethanol)
Alcohol given orally (0.5 grams of alcohol per kg of fat-free mass) Alcohol given iv with a clamp ( 6% v/v alcohol prepared in 0.5% normal saline). The infusion rate will exponentially increase from the start of the infusion until the target BrAC of 0.6g/L (60mg%) is reached at 15 min, followed by an exponentially decreasing infusion rate, which will be tapered to a constant steady-state value to clamp the BrAC at the target value for a predetermined duration of 180 min.
Women, non-operated control
  • Alcohol orally administered (0.5 grams per kg of Fat-free mass) after overnight fast or after a standard meal
  • Alcohol administered IV using an alcohol clamp (target concentration of 0.6g/L after an overnight fast or one hour after consuming a standard mixed meal)
Drug: Alcohol (Ethanol)
Alcohol given orally (0.5 grams of alcohol per kg of fat-free mass) Alcohol given iv with a clamp ( 6% v/v alcohol prepared in 0.5% normal saline). The infusion rate will exponentially increase from the start of the infusion until the target BrAC of 0.6g/L (60mg%) is reached at 15 min, followed by an exponentially decreasing infusion rate, which will be tapered to a constant steady-state value to clamp the BrAC at the target value for a predetermined duration of 180 min.
Men, non-operated control
  • Alcohol orally administered (0.5 grams per kg of Fat-free mass) after overnight fast or after a standard meal
  • Alcohol administered IV using an alcohol clamp (target concentration of 0.6g/L after an overnight fast or one hour after consuming a standard mixed meal)
Drug: Alcohol (Ethanol)
Alcohol given orally (0.5 grams of alcohol per kg of fat-free mass) Alcohol given iv with a clamp ( 6% v/v alcohol prepared in 0.5% normal saline). The infusion rate will exponentially increase from the start of the infusion until the target BrAC of 0.6g/L (60mg%) is reached at 15 min, followed by an exponentially decreasing infusion rate, which will be tapered to a constant steady-state value to clamp the BrAC at the target value for a predetermined duration of 180 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood alcohol concentrations (BAC)
Time Frame: From zero to up to 180 minutes post alcohol administration
The concentration of alcohol measured in arterialized venous blood and estimated from breath )BrAC)
From zero to up to 180 minutes post alcohol administration
Subjective effects of alcohol
Time Frame: Before and after (10-180 min) they consume the alcoholic beverage or receive the IV infusion for the alcohol clamp.
We will use valid psychometrically sound instruments to assess alcohol's subjective effects (e.g., stimulant and sedative effects of alcohol)
Before and after (10-180 min) they consume the alcoholic beverage or receive the IV infusion for the alcohol clamp.
Plasma glucose concentrations
Time Frame: Before and after (10-180 min) they consume the alcoholic beverage.
The concentration of glucose measured in plasma.
Before and after (10-180 min) they consume the alcoholic beverage.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut hormones and other peptides
Time Frame: Before and after (10-180 min) they consume the alcoholic beverage
Gut hormones such as ghrelin, glucagon-like peptide and others
Before and after (10-180 min) they consume the alcoholic beverage

Collaborators and Investigators

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

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

Carle Foundation Hospital

Investigators

  • Principal Investigator: Marta Y Pepino de Gruev, PhD, University of Illinois at Urbana-Champaign

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 (Actual)

July 31, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24444 (old); IRB24-0173 (new)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be findable for the research community through NIAAADA. The research community will have access to data at the time of publication or when the award ends, whichever is sooner. NIAAADA will make decisions about how long to preserve the data.

IPD Sharing Time Frame

The research community will have access to data at the time of publication or when the award ends, whichever is sooner. NIAAADA will make decisions about how long to preserve the data.

IPD Sharing Access Criteria

To request access of the data, researchers will use the standard processes at NIMH Data Archive (NDA) , and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Subscribe