Effects of Alcohol After Bariatric Surgery (RBA)

University of Illinois at Urbana-Champaign

Status: Unknown

Conditions: Obesity

Treatments: Other: Alcohol challenge test Placebo visit first; Other: Alcohol challenge test Alcohol visit first

Study type: Observational

Funder types: Other

Identifiers

NCT01843257

NCT01843257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 7 patient groups

Gastric Bypass longitudinal

Description:

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.

Treatment:

Other: Alcohol challenge test Alcohol visit first

Other: Alcohol challenge test Placebo visit first

Gastric Banding longitudinal

Description:

Morbidly obese subjects undergoing laparoscopic gastric banding 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.

Treatment:

Other: Alcohol challenge test Alcohol visit first

Other: Alcohol challenge test Placebo visit first

Gastric Bypass (cross-sectional)

Description:

Subjects who underwent gastric bypass surgery 1-5 years ago. 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.

Treatment:

Other: Alcohol challenge test Alcohol visit first

Other: Alcohol challenge test Placebo visit first

Gastric Banding (cross-sectional)

Description:

Subjects who underwent gastric banding surgery 1-5 years ago. 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.

Treatment:

Other: Alcohol challenge test Alcohol visit first

Other: Alcohol challenge test Placebo visit first

Sleeve gastrectomy (longitudinal)

Description:

Morbidly obese subjects who will undergo sleeve gastrectomy. 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.

Treatment:

Other: Alcohol challenge test Alcohol visit first

Other: Alcohol challenge test Placebo visit first

Sleeve gastrectomy (cross-sectional)

Description:

Subjects who underwent sleeve gastrectomy 1-5 years ago. 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.

Treatment:

Other: Alcohol challenge test Alcohol visit first

Other: Alcohol challenge test Placebo visit first

No bariatric surgery control

Description:

Control group of women with age and BMI similar to those in the cross-sectional arm of the study who have not undergone bariatric 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.

Treatment:

Other: Alcohol challenge test Alcohol visit first

Other: Alcohol challenge test Placebo visit first