Alcohol After Bariatric Surgery 2

NCT ID: NCT06257771

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2028-08-31

Brief 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.

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.

Conditions

Sleeve Gastrectomy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Alcohol (Ethanol)

Intervention Type: 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.

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)

Alcohol (Ethanol)

Intervention Type: 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.

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)

Alcohol (Ethanol)

Intervention Type: 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.

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)

Alcohol (Ethanol)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carle Foundation Hospital

OTHER

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta Y Pepino de Gruev, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

University of Illinois at Urbana Champaign

Urbana, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mariel Molina-Castro, BS

Role: CONTACT

marielm2@illinois.edu

217-300-4709

Facility Contacts

Mariel Molina-Castro, BS

Role: primary

marielm2@illinois.edu

217-300-4709

Other Identifiers

24444 (old); IRB24-0173 (new)

Identifier Type: -

Identifier Source: org_study_id