Alcohol and Bariatric Surgery

Obesity Clinical Trial

— ABS  

Official title:

Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02766322
• Other study ID #: 16135
• Secondary ID: 17205
• Status: Terminated
• Start date: March 2016
• Est. completion date: May 25, 2022

Study information

• Verified date: February 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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) 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Oral Alcohol challenge test Alcohol visit first
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 (visit 1 alcohol, visit 2 placebo).
• Oral Alcohol challenge test Placebo visit first
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 (visit 1 placebo, visit 2 alcohol).
• Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
• Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Carle Foundation Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Acevedo MB, Eagon JC, Bartholow BD, Klein S, Bucholz KK, Pepino MY. Sleeve gastrectomy surgery: when 2 alcoholic drinks are converted to 4. Surg Obes Relat Dis. 2018 Mar;14(3):277-283. doi: 10.1016/j.soard.2017.11.010. Epub 2017 Nov 10. — View Citation

Acevedo MB, Teran-Garcia M, Bucholz KK, Eagon JC, Bartholow BD, Burd NA, Khan N, Rowitz B, Pepino MY. Alcohol sensitivity in women after undergoing bariatric surgery: a cross-sectional study. Surg Obes Relat Dis. 2020 Apr;16(4):536-544. doi: 10.1016/j.soa — View Citation

Seyedsadjadi N, Acevedo MB, Alfaro R, Ramchandani VA, Plawecki MH, Rowitz B, Pepino MY. Site of Alcohol First-Pass Metabolism Among Women. JAMA Netw Open. 2022 Mar 1;5(3):e223711. doi: 10.1001/jamanetworkopen.2022.3711. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e2212773. — View Citation

Seyedsadjadi N, Ramchandani VA, Plawecki MH, Kosobud AEK, O'Connor S, Rowitz B, Pepino MY. Fat-free mass accounts for most of the variance in alcohol elimination rate in women. Alcohol Clin Exp Res (Hoboken). 2023 May;47(5):848-855. doi: 10.1111/acer.15047. Epub 2023 Mar 14. — View Citation

Seyedsadjadi N, Ramchandani VA, Plawecki MH, Kosobud AEK, O'Connor S, Rowitz B, Pepino MY. Response to commentary on: "Fat-free mass accounts for most of the variance in alcohol elimination rate in women". Alcohol Clin Exp Res (Hoboken). 2023 Sep;47(9):1646-1648. doi: 10.1111/acer.15142. Epub 2023 Jul 11. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the peak blood alcohol level achieved before-after bariatric surgery and among bariatric surgery and control groups	Time to reach peak blood alcohol levels and height of blood alcohol levels will be examined before and after surgery and compared between those who had gastric bypass or gastric sleeve versus lap banding and the non-surgery control group.	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.
Primary	Change in alcohol subjective effects from pre- to post- bariatric surgery and among bariatric surgery and control groups	Validated instruments (such as the Addiction Research Center Inventory and the biphasic alcohol effect scale) will be used to measure alcohol's subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage as well as receiving alcohol vs placebo orally or alcohol intravenously	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.
Primary	Change in the area under the curve for blood alcohol concentration (BAC) versus time pre- to post-bariatric surgery and among different bariatric surgery groups and controls	The area under the curve for BAC will be examined before and after surgery and compared among those who had gastric bypass or gastric sleeve versus lap banding or the non-surgery control group.	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.
Primary	Change in the rate of alcohol elimination between pre- and post-surgery and among the different bariatric surgery groups and the control groups.	The systemic alcohol elimination rate calculated from the alcohol infusion rate during the iv alcohol clamp technique will be compared pre- to post- surgery and among bariatric and control groups	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	Changes on alcohol's effects on glucose homeostasis and concentration of gut peptides [re- to post-surgery and among bariatric surgery gropus and control groups.		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.