Recruiting

Alcohol Processing

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT06257771

Conditions

Sleeve Gastrectomy

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Not accepted

Interventions

Alcohol (Ethanol)

Study Details

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.

Conditions

Sleeve Gastrectomy

Study ID

NCT06257771

Start date

Jul 31, 2024

Status verified date

Sep, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

88 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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)

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)

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)

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.

Primary outcome measure

  • Blood alcohol concentrations (BAC) [ Time Frame: 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. ]
  • Plasma glucose concentrations [ Time Frame: Before and after (10-180 min) they consume the alcoholic beverage. ]

Central Contacts and Locations

Central contacts

Rafael Guimaraes de Lima, PhD

217-300-2374rafael5@illinois.edu

Rafael Guimaraes de Lima, PhD

217-300-4709rafael5@illinois.edu

Locations

University of Illinois at Urbana Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Mariel Molina-Castro, BS

217-300-4709marielm2@illinois.edu

Principal Investigator:

Marta Y Pepino, PhD

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Alcohol metabolism
  • Bariatric surgery
  • Hypoglycemia
  • Metabolic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2026-09-08.