Alcohol After Bariatric Surgery 2
ABS2
Pharmacokinetics and Responses to Alcohol After Bariatric Surgery
1 other identifier
observational
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
March 11, 2025
March 1, 2025
3.9 years
February 5, 2024
March 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Blood alcohol concentrations (BAC)
The concentration of alcohol measured in arterialized venous blood and estimated from breath )BrAC)
From zero to up to 180 minutes post alcohol administration
Subjective effects of alcohol
We will use valid psychometrically sound instruments to assess alcohol's subjective effects (e.g., stimulant and sedative effects of alcohol)
Before and after (10-180 min) they consume the alcoholic beverage or receive the IV infusion for the alcohol clamp.
Plasma glucose concentrations
The concentration of glucose measured in plasma.
Before and after (10-180 min) they consume the alcoholic beverage.
Secondary Outcomes (1)
Gut hormones and other peptides
Before and after (10-180 min) they consume the alcoholic beverage
Study Arms (4)
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)
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)
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)
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)
Interventions
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.
Eligibility Criteria
Carle Foundation Hospital and community sample
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Urbana Champaign
Urbana, Illinois, 61801, United States
Biospecimen
Plasma samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marta Y Pepino de Gruev, PhD
University of Illinois at Urbana-Champaign
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2024
First Posted
February 14, 2024
Study Start
July 31, 2024
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- The research community will have access to data at the time of publication or when the award ends, whichever is sooner. NIAAADA will make decisions about how long to preserve the data.
- Access Criteria
- To request access of the data, researchers will use the standard processes at NIMH Data Archive (NDA) , and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable
Data will be findable for the research community through NIAAADA. The research community will have access to data at the time of publication or when the award ends, whichever is sooner. NIAAADA will make decisions about how long to preserve the data.