| NCT ID | NCT06257771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Urbana-Champaign |
| Condition | Sleeve Gastrectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2024-07-31 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marta Y Pepino de Gruev, PhD
PRINCIPAL INVESTIGATOR
University of Illinois at Urbana-Champaign
Frequently Asked Questions
Who can join the NCT06257771 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 64 Years, studying Sleeve Gastrectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06257771 currently recruiting?
Yes, NCT06257771 is actively recruiting participants. Contact the research team at marielm2@illinois.edu for enrollment information.
Where is the NCT06257771 trial being conducted?
This trial is being conducted at Urbana, United States.
Who is sponsoring the NCT06257771 clinical trial?
NCT06257771 is sponsored by University of Illinois at Urbana-Champaign. The principal investigator is Marta Y Pepino de Gruev, PhD at University of Illinois at Urbana-Champaign. The trial plans to enroll 88 participants.