ClinicalTrials.gg
RecruitingNCT06257771ABS2Updated Sep 8, 2026

Alcohol After Bariatric Surgery 2

An observational study in Sleeve Gastrectomy, sponsored by University of Illinois at Urbana-Champaign. Recruiting at 1 site in United States. Open to participants aged 21 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of Illinois at Urbana-Champaign · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
88
Ages
21 Years to 64 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Sleeve Gastrectomy

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Keywords

  • Alcohol metabolism
  • Bariatric surgery
  • Hypoglycemia
  • Metabolic surgery
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In context

Hypoglycemia

706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.

This study's planned enrollment of 88 is close to the median of 86 across 131 observational studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 64 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Carle Foundation Hospital and community sample

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , , race , and alcohol pattern of consumption equivalent to participants in the SG surgery groups

Exclusion criteria

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 as determined by a study physician to present a safety risk
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
88 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

  • 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)

  • 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)

  • 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)

Interventions

  • 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.

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What researchers measure

Primary outcomes

  1. Blood alcohol concentrations (BAC)

    The concentration of alcohol measured in arterialized venous blood and estimated from breath )BrAC)

    Time frame: From zero to up to 180 minutes post alcohol administration

  2. Subjective effects of alcohol

    We will use valid psychometrically sound instruments to assess alcohol's subjective effects (e.g., stimulant and sedative 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.

  3. Plasma glucose concentrations

    The concentration of glucose measured in plasma.

    Time frame: Before and after (10-180 min) they consume the alcoholic beverage.

Secondary outcomes

  1. Gut hormones and other peptides

    Gut hormones such as ghrelin, glucagon-like peptide and others

    Time frame: Before and after (10-180 min) they consume the alcoholic beverage

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Informed consent form

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.

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

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06257771
Collaborators
Carle Foundation Hospital
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Jul 31, 2024
Primary completion
Jul 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Rafael Guimaraes de Lima, PhD
Contact
rafael5@illinois.edu
217-300-2374
Rafael Guimaraes de Lima, PhD
Contact
rafael5@illinois.edu
217-300-4709
Marta Y Pepino de Gruev, PhD
principal investigator · University of Illinois at Urbana-Champaign

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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