Alcohol and Bariatric Surgery

Terminated

• Conditions: Obesity

• Registration Number: NCT02766322
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief Summary

The investigators wish to study the effects of alcohol on three forms of bariatric surgery, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and laparoscopic adjustable gastric banding (LAGB) and compare them with a non-surgical group. The surgery is not part of the clinical trial. If insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body, 2) the effects of alcohol on mood, and 3) the effects of alcohol on driving.

Detailed Description

The study includes seven groups of women: One group will be undergoing RYGB another group will be undergoing LAGB, a third group will be undergoing SG, the fourth group will be women who underwent RYGB 1-5 years ago, the fifth group will be women who underwent LAGB 1-5 years ago, the sixth group will be women who underwent SG 1-5 years ago and the seventh group will be women who have equivalent age and body mass index than women in the groups who underwent RYGB or SG 1-5 years ago but did not have bariatric surgery (non-surgical group).

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-09
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Female
• Drink at least 1 standard alcoholic beverage/ month
• Underwent RYGB, SG, or LAGB 1-5 years ago or will undergo RYGB, SG, or LAGB surgery
• Did not undergo bariatric surgery (for the non-surgical group)

Exclusion Criteria

• Male
• Smoker or quit < 6 months ago
• Anemia
• Liver disease
• Body weight > 450 pounds
• Taking medications that can interact with alcohol metabolism or the subjective effects of alcohol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the rate of alcohol elimination between pre- and post-surgery and among the different bariatric surgery groups and the control groups.	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	The systemic alcohol elimination rate calculated from the alcohol infusion rate during the iv alcohol clamp technique will be compared pre- to post- surgery and among bariatric and control groups
Change in the area under the curve for blood alcohol concentration (BAC) versus time pre- to post-bariatric surgery and among different bariatric surgery groups and controls	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	The area under the curve for BAC will be examined before and after surgery and compared among those who had gastric bypass or gastric sleeve versus lap banding or the non-surgery control group.
Change in the peak blood alcohol level achieved before-after bariatric surgery and among bariatric surgery and control groups	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	Time to reach peak blood alcohol levels and height of blood alcohol levels will be examined before and after surgery and compared between those who had gastric bypass or gastric sleeve versus lap banding and the non-surgery control group.
Change in alcohol subjective effects from pre- to post- bariatric surgery and among bariatric surgery and control groups	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	Validated instruments (such as the Addiction Research Center Inventory and the biphasic alcohol effect scale) will be used to measure alcohol's subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage as well as receiving alcohol vs placebo orally or alcohol intravenously

Secondary Outcome Measures

Name	Time	Method
Changes in alcohol's effects on insulin [pre- to post-surgery and among bariatric surgery groups and control groups.	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	pmol/L
Changes in alcohol's effects on C-peptide [pre- to post-surgery and among bariatric surgery groups and control groups.	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	nmol/L
Changes in alcohol's effects on FGF21 [pre- to post-surgery and among bariatric surgery groups and control groups.	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	pg/ml
Changes in alcohol's effects on ghrelin [pre- to post-surgery and among bariatric surgery groups and control groups.	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	pg/ml
Changes in alcohol's effects on GLP-1 [pre- to post-surgery and among bariatric surgery groups and control groups.	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	pmol/L
Changes in alcohol's effects on glucose homeostasis [pre- to post-surgery and among bariatric surgery groups and control groups.	Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.	mmol/L

Trial Locations

Locations (1)

University of Illinois at Urbana Champaign; 🇺🇸 Urbana, Illinois, United States