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NCT Number: NCT06257771

Alcohol After Bariatric Surgery 2

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.

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Key information

Conditions

Sleeve Gastrectomy Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

Location status: Recruiting

Location contact

Mariel Molina-Castro, BS

CONTACT

[email protected]

217-300-4709

Marta Y Pepino, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol (Ethanol)

Drug

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.

Primary outcomes

  1. 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)

  2. 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)

  3. Plasma glucose concentrations

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

    The concentration of glucose measured in plasma.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mariel Molina-Castro, BS

CONTACT

[email protected]

217-300-4709

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Carle Foundation Hospital

Registry information

Official study title

Pharmacokinetics and Responses to Alcohol After Bariatric Surgery

Acronym: ABS2

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 14, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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