Alcohol and Bariatric Surgery (ABS)

U

University of Illinois at Urbana-Champaign

Status

Unknown

Conditions

Obesity

Treatments

Other: Intravenous Alcohol Self-administration Test
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Placebo visit first

Study type

Observational

Funder types

Other

Identifiers

NCT02766322
16135

Details and patient eligibility

About

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.

Full 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).

Enrollment

112 estimated patients

Sex

Female

Ages

21 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

112 participants in 7 patient groups

Gastric Bypass longitudinal
Description:
Morbidly obese subjects undergoing gastric bypass surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose ~ 16% of their presurgery body weight.
Treatment:
Other: Oral Alcohol challenge test Placebo visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Self-administration Test
Gastric Banding longitudinal
Description:
Morbidly obese subjects undergoing laparoscopic gastric banding surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose ~ 16% of their presurgery body weight.
Treatment:
Other: Oral Alcohol challenge test Placebo visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Self-administration Test
Sleeve gastrectomy longitudinal
Description:
Morbidly obese subjects undergoing sleeve gastrectomy surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose ~ 16% of their presurgery body weight..
Treatment:
Other: Oral Alcohol challenge test Placebo visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Self-administration Test
Gastric Bypass (cross-sectional)
Description:
Subjects who underwent gastric bypass surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Treatment:
Other: Oral Alcohol challenge test Placebo visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Self-administration Test
Gastric Banding (cross-sectional)
Description:
Subjects who underwent gastric banding surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Treatment:
Other: Oral Alcohol challenge test Placebo visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Self-administration Test
Sleeve gastrectomy (cross-sectional)
Description:
Subjects who underwent sleeve gastrectomy surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Treatment:
Other: Oral Alcohol challenge test Placebo visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Self-administration Test
Non-surgical group
Description:
Subjects who are age and body mass index equivalent to gastric bypass (cross-sectional) and Sleeve gastrectomy (cross-sectional) but did not undergo any type of bariatric surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Treatment:
Other: Oral Alcohol challenge test Placebo visit first
Other: Intravenous Alcohol Challenge Test (Clamp)
Other: Oral Alcohol challenge test Alcohol visit first
Other: Intravenous Alcohol Self-administration Test

Trial contacts and locations

1

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Central trial contact

Neda Seyedsadjadi, PhD; Christine Canfield, BS, CCRP

Data sourced from clinicaltrials.gov

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