Alcohol After Bariatric Surgery 2

Sleeve Gastrectomy Clinical Trial

— ABS2  

Official title:

Pharmacokinetics and Responses to Alcohol After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257771
• Other study ID #: 24444
• Status: Recruiting
• Start date: April 2024
• Est. completion date: August 2028

Study information

• Verified date: February 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: Mariel Molina-Castro, BS
• Phone: 217-300-4709
• Email: marielm2[@]illinois.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 2028
• Est. primary completion date: July 2028
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleeve Gastrectomy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Carle Foundation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	Plasma glucose concentrations	The concentration of glucose measured in plasma.	Before and after (10-180 min) they consume the alcoholic beverage.
Secondary	Gut hormones and other peptides	Gut hormones such as ghrelin, glucagon-like peptide and others	Before and after (10-180 min) they consume the alcoholic beverage