RecruitingNCT06257771

Alcohol After Bariatric Surgery 2

Pharmacokinetics and Responses to Alcohol After Bariatric Surgery

Sponsor

University of Illinois at Urbana-Champaign

Enrollment

88 participants

Start Date

Jul 31, 2024

Study Type

OBSERVATIONAL

Conditions

Sleeve Gastrectomy

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.

Eligibility

Min Age: 21 YearsMax Age: 64 Years

Inclusion Criteria7

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 Criteria10

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

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Interventions

DRUGAlcohol (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.