Clinical trial NCT01843257: Effects of Alcohol After Bariatric Surgery
Official title: Pharmacokinetics and Pharmacological Effects of Alcohol After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Alcohol intake after bariatric surgery
Alcohol and bariatric surgery
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
name: Washington University School of Medicine
First posted: 2013-04-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bariatric surgery clinic

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.

Detailed description: The study includes seven groups of women: One group will be undergoing gastric bypass, another group will be undergoing lap banding, a third group will be undergoing sleeve gastrectomy, the fourth group will be women who underwent gastric bypass 1-5 years ago, the fifth group will be women who underwent lap banding 1-5 years ago, the sixth group will be women who underwent sleeve gastrectomy 1-5 years ago, and the seventh group will be a control group who have not undergone bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Women
* Drink alcohol at least once per month

Exclusion Criteria:

* Men
* Drinks more than 7 standard drinks per week or more than 4 standard drinks in a period of 2 hours for the month before enrolling in the study.
* Regular use of drugs of abuse or use of any medication interacting with alcohol pharmacokinetics or pharmacologic effects.
* Alcohol dependence
* Pregnancy, lactation or not using effective methods of birth control
* Smoking
* Anemia
* Liver disease

Primary outcomes:
measure: Change from before bariatric surgery in alcohol's Tmax, Cmax, area under the curve and elimination rates at approximately 9 months after bariatric surgery
timeFrame: 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.
measure: Change from before bariatric surgery in alcohol subjective effects at approximately 9 months after bariatric surgery
timeFrame: 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
timeFrame: 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.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: University of Illinois at Urbana Champaign
state: Missouri
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Marta Y Pepino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pepino MY, Okunade AL, Eagon JC, Bartholow BD, Bucholz K, Klein S. Effect of Roux-en-Y Gastric Bypass Surgery: Converting 2 Alcoholic Drinks to 4. JAMA Surg. 2015 Nov;150(11):1096-8. doi: 10.1001/jamasurg.2015.1884. No abstract available.