Alcohol After Bariatric Surgery 2

Part of paid clinical trials in Urbana, Illinois.

Sponsor
University of Illinois at Urbana-Champaign
Study ID
NCT06257771
Status
Recruiting
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Conditions

  • Sleeve Gastrectomy

Eligibility Criteria

Sex
ALL
Age
21 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Alcohol (Ethanol) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Mar 2025
Primary completion
Jul 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
88 participants (estimated)

Arms

  • Arm: 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)
  • Arm: 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)
  • Arm: 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)
  • Arm: 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)

Primary Outcome Measure

Blood alcohol concentrations (BAC) [ Time Frame: From zero to up to 180 minutes post alcohol administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at Urbana ChampaignUrbanaIllinois61801
Mariel Molina-Castro, BS
[email protected]
217-300-4709
Marta Y Pepino, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Illinois at Urbana Champaign· Urbana, IL

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