Brief Summary

The investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. 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 blood sugar; and 3) the effects of alcohol on mood.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.4 years study duration

Study Start

First participant enrolled

April 1, 2013

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed

8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed

8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed

Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

8.4 years

First QC Date

April 22, 2013

Last Update Submit

April 26, 2021

Conditions

Obesity

Keywords

Alcohol intake after bariatric surgeryAlcohol and bariatric surgery

Outcome Measures

Primary Outcomes (2)

Change from before bariatric surgery in alcohol's Tmax, Cmax, area under the curve and elimination rates at approximately 9 months after bariatric surgery
Time to reach maximum peak blood alcohol levels, alcohol area under the time-concentration curve and alcohol's constant of elimination will be examined before and after surgery and compared between those who had gastric bypass versus lap banding.
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
Validated instruments (such as the Addiction Research Center Inventory) will be used to measured alcohol's subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage.
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 (1)

Change from before bariatric surgery on alcohol's effects on glucose homeostasis at approximately 9 months after bariatric surgery
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.

Study Arms (7)

Gastric Bypass longitudinal

Morbidly obese subjects undergoing gastric bypass surgery. Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion before surgery. The two testing sessions will be repeated \~ 9 months after surgery.