Sleeve GastrectomyABS2NCT06257771
Alcohol After Bariatric Surgery 2
An observational study of Sleeve Gastrectomy, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Sleeve Gastrectomy
- What is being tested?
- Alcohol (Ethanol)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Adult
Study population: Carle Foundation Hospital and community sample
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana Champaign
Urbana, Illinois, 61801
Mariel Molina-Castro, BS, 217-300-4709, marielm2@illinois.edu
Marta Y Pepino, PhD
About this study
Official title: Pharmacokinetics and Responses to Alcohol After Bariatric Surgery
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?
Read more
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.
Read the detailed description
The primary goal of the proposed study is to determine sex-related differences in the impact of Sleeve Gastrectomy (SG) on the pharmacokinetics (Aim 1), subjective effects (Aim 2), and glycemic effects (Aim 3) in the fasted versus prandial state when alcohol is ingested or given intravenously clamped (the gold standard to measure alcohol elimination rate and acute alcohol tolerance). We will use a cross-sectional study to compare participants who underwent SG surgery 1-5 years ago with matched non-operated controls (both sexes). This project will answer the questions of whether there are sex-related differences in the impact of SG on alcohol's pharmacokinetics and pharmacologic effects, whether drinking alcohol with a meal is effective post-SG, and clarify the site of alcohol first-pass metabolism in men. Findings from this study will contribute to evidence-based recommendations on the impact of SG on alcohol-related toxic effects and could help expand the knowledge base of sex-related differences in human alcohol pharmacokinetics.
- Conditions
- Sleeve Gastrectomy
- Being tested
- Alcohol (Ethanol)
- Keywords
- Alcohol metabolism, Bariatric surgery, Hypoglycemia, Metabolic surgery
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Alcohol (Ethanol) | |
| 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) Receives: Drug: Alcohol (Ethanol) | |
| 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) Receives: Drug: Alcohol (Ethanol) | |
| 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) Receives: Drug: Alcohol (Ethanol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood alcohol concentrations (BAC)
The concentration of alcohol measured in arterialized venous blood and estimated from breath )BrAC)
Measured: 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)
Measured: 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.
Measured: Before and after (10-180 min) they consume the alcoholic beverage.
Secondary outcomes (1)
Gut hormones and other peptides
Gut hormones such as ghrelin, glucagon-like peptide and others
Measured: Before and after (10-180 min) they consume the alcoholic beverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start31 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleeve GastrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Carle Foundation Hospital
- Responsible party
- Sponsor
- Investigators
- Marta Y Pepino de Gruev, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257771
- Sponsor's protocol ID
- 24444 (old); IRB24-0173 (new)
- Acronym
- ABS2
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Responses to Alcohol After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06257771
- Acronym / sponsor ID
- ABS2 / 24444 (old); IRB24-0173 (new)
- Conditions
- Sleeve Gastrectomy
- Keywords
- Alcohol metabolism, Bariatric surgery, Hypoglycemia, Metabolic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Carle Foundation Hospital
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary goal of the proposed study is to determine sex-related differences in the impact of Sleeve Gastrectomy (SG) on the pharmacokinetics (Aim 1), subjective effects (Aim 2), and glycemic effects (Aim 3) in the fasted versus prandial state when alcohol is ingested or given intravenously clamped (the gold standard to measure alcohol elimination rate and acute alcohol tolerance). We will use a cross-sectional study to compare participants who underwent SG surgery 1-5 years ago with matched non-operated controls (both sexes). This project will answer the questions of whether there are sex-related differences in the impact of SG on alcohol's pharmacokinetics and pharmacologic effects, whether drinking alcohol with a meal is effective post-SG, and clarify the site of alcohol first-pass metabolism in men. Findings from this study will contribute to evidence-based recommendations on the impact of SG on alcohol-related toxic effects and could help expand the knowledge base of sex-related differences in human alcohol pharmacokinetics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Women 1-5 years post-SG | – | Drug: Alcohol (Ethanol)* 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 | – | Drug: Alcohol (Ethanol)* 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 | – | Drug: Alcohol (Ethanol)* 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 | – | Drug: Alcohol (Ethanol)* 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) |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- Carle Foundation Hospital and community sample
Key inclusion criteria (7 listed)
- Surgery groups:
- 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
Key exclusion criteria (10 listed)
- For all groups (surgery and non-surgery groups)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol (Ethanol)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. | Drug | Men 1-5 years post-SG, Men, non-operated control, Women 1-5 years post-SG, Women, non-operated control |
Primary outcome
Blood alcohol concentrations (BAC)
Time frame: From zero to up to 180 minutes post alcohol administration
The concentration of alcohol measured in arterialized venous blood and estimated from breath )BrAC)
Subjective effects of alcohol
Time frame: Before and after (10-180 min) they consume the alcoholic beverage or receive the IV infusion for the alcohol clamp.
We will use valid psychometrically sound instruments to assess alcohol's subjective effects (e.g., stimulant and sedative effects of alcohol)
Plasma glucose concentrations
Time frame: Before and after (10-180 min) they consume the alcoholic beverage.
The concentration of glucose measured in plasma.
1 secondary outcome
Gut hormones and other peptides
Time frame: Before and after (10-180 min) they consume the alcoholic beverage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Y Pepino de Gruev, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleeve Gastrectomy, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Guimaraes de Lima, PhD (217-300-2374, rafael5@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood alcohol concentrations (BAC) (time frame: From zero to up to 180 minutes post alcohol administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.