RecruitingNot Applicable

Alcohol After Bariatric Surgery 2

United States88 participantsStarted 2024-07-31

Plain-language 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.

Who can participate

Age range

21 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood alcohol concentrations (BAC)

Timeframe: From zero to up to 180 minutes post alcohol administration

Subjective effects of alcohol

Timeframe: Before and after (10-180 min) they consume the alcoholic beverage or receive the IV infusion for the alcohol clamp.

Plasma glucose concentrations

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

Trial details

NCT IDNCT06257771

SponsorUniversity of Illinois at Urbana-Champaign

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07

Contact for this trial

Mariel Molina-Castro, BS

217-300-4709 marielm2@illinois.edu

View on ClinicalTrials.gov More Sleeve Gastrectomy trials