Overview

This trial is active, not recruiting.

Condition obesity
Treatments oral alcohol challenge test alcohol visit first, oral alcohol challenge test placebo visit first, intravenous alcohol challenge test alcohol first, intravenous alcohol challenge test placebo first
Sponsor Washington University School of Medicine
Start date March 2016
End date March 2021
Trial size 112 participants
Trial identifier NCT02766322, 201512019

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). 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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Change from before bariatric surgery in the peak blood alcohol level and at approximately 9 months after bariatric surgery.
time frame: 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.
Change from before bariatric surgery in alcohol subjective effects at approximately 9 months after bariatric surgery
time frame: 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.
Change from before bariatric surgery in the area under the curve for blood alcohol concentration (BAC) versus time and at approximately 9 months after bariatric surgery.
time frame: 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.
Change from before bariatric surgery in the rate of alcohol elimination and at approximately 9 months after bariatric surgery.
time frame: 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.

Secondary Outcomes

Measure
Change from before bariatric surgery on alcohol's effects on glucose homeostasis at approximately 9 months after bariatric surgery.
time frame: 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.
Change from before bariatric surgery on alcohol's effect on fitness to drive compared to approximately 9 months after bariatric surgery.
time frame: 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.

Eligibility Criteria

Female participants from 21 years up to 65 years old.

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 (control 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

Additional Information

Official title Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery
Principal investigator Samuel Klein, MD
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 a control group who have not undergone bariatric surgery.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.