Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Carle Foundation Hospital | OTHER |
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women 1-5 years post-SG |
|
| |
| Men 1-5 years post-SG |
|
| |
| Women, non-operated control |
|
| |
| Men, non-operated control |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Surgery groups:
Non-surgery control group
Exclusion Criteria:
For all groups (surgery and non-surgery groups)
Not provided
Not provided
Carle Foundation Hospital and community sample
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariel Molina-Castro, BS | Contact | 217-300-4709 | marielm2@illinois.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marta Y Pepino de Gruev, PhD | University of Illinois at Urbana-Champaign | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana Champaign | Recruiting | Urbana | Illinois | 61801 | United States |
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.
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.
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
Not provided
Not provided
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Plasma samples
|