Alcohol After Bariatric Surgery 2
ConditionSleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-64
SponsorUniversity of Illinois at Urbana-Champaign
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Male and female who did not undergo bariatric surgery
Disqualifiers
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
Trial population
Carle Foundation Hospital and community sample
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Alcohol (Ethanol)
DrugAlcohol 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.
Treatment groups
88 Participants
are divided into 4 treatment groupsGroup A: Women 1-5 years post-SG1 intervention
Group B: Men 1-5 years post-SG1 intervention
Group C: Women, non-operated control1 intervention
Group D: Men, non-operated control1 intervention
Trial outcomes
Primary outcomes
1
Blood alcohol concentrations (BAC)
The concentration of alcohol measured in arterialized venous blood and estimated from breath )BrAC)
Time frame
From zero to up to 180 minutes post alcohol administration2
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)
Time frame
Before and after (10-180 min) they consume the alcoholic beverage or receive the IV infusion for the alcohol clamp.3
Plasma glucose concentrations
The concentration of glucose measured in plasma.
Time frame
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
Time frame
Before and after (10-180 min) they consume the alcoholic beverageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Urbana-Champaign
Lead sponsor
Carle Foundation Hospital
Collaborator
Source ClinicalTrials.gov