Actively Recruiting
Pharmacokinetics and Responses to Alcohol After Bariatric Surgery
Led by University of Illinois at Urbana-Champaign · Updated on 2025-03-11
88
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Urbana-Champaign
Lead Sponsor
C
Carle Foundation Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the body processes alcohol and how alcohol affects mood and blood sugar in men and women who have undergone sleeve gastrectomy, a type of weight-loss surgery. The study aims to find out if there are differences between men and women in how alcohol is handled after this surgery, and how drinking alcohol on an empty stomach versus after a meal affects blood sugar control. The study compares participants who had sleeve gastrectomy 1 to 5 years ago with people of similar age, body composition, and drinking habits who did not have surgery. Participants will undergo two types of alcohol tests: one where alcohol is given orally at a dose based on fat-free mass, either after fasting overnight or after a standard meal, and another where alcohol is administered intravenously using a controlled infusion to maintain a set blood alcohol concentration. These tests allow researchers to measure alcohol absorption, subjective effects, and blood sugar responses in different conditions. During the study, participants will have blood alcohol levels, subjective alcohol effects, and blood glucose measured from before alcohol intake up to 180 minutes afterward. Gut hormones and other peptides will also be monitored. Researchers will compare responses between men and women and between those who had surgery and those who did not. The study will last until August 2028, and participation involves scheduled visits for testing under fasting and fed states.
CONDITIONS
Brief Title
Alcohol After Bariatric Surgery 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 21 to 64 years
- Drink at least 1 standard alcoholic drink per month but no more than 7 per week for women or no more than 14 per week for men
- For surgery group: undergone sleeve gastrectomy 1 to 5 years ago
- For non-surgery group: no bariatric surgery and matched in age, BMI, race, and alcohol consumption patterns to surgery group participants
You will not qualify if you...
- Smoking currently or quit smoking less than 2 months ago
- Pregnant or breastfeeding
- Taking medications that affect alcohol metabolism
- Having anemia
- Having gastritis, colitis, Crohn's disease, malabsorptive or inflammatory diseases
- Having liver disease, kidney disease, cancer within the last 5 years, stroke, or severe organ dysfunction
- Weighing over 450 pounds
- Having alcohol use disorder
- Regular use or misuse of addictive drugs
- Abnormal EKG posing a safety risk as determined by study physician
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo oral and intravenous alcohol administration after fasting or consuming a standard meal to assess blood alcohol concentrations, subjective effects, and plasma glucose levels.
1 to 2 visits depending on alcohol administration method
Duration - Up to 180 minutes after alcohol administration
Participants are observed to contribute data on sex-related differences in alcohol pharmacokinetics and effects post-sleeve gastrectomy or in matched non-operated controls.
Observations during the diagnostic visits
Trial Site Locations
Total: 1 location
1
University of Illinois at Urbana Champaign
Urbana, Illinois, United States, 61801
Actively Recruiting
Research Team
M
Mariel Molina-Castro, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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