Clinical trial NCT02766322: Alcohol and Bariatric Surgery
Official title: Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: Alcohol metabolism
Bariatric surgery
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Carle Foundation Hospital
First posted: 2016-05-09
Enrollment: 54
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: 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 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the peak blood alcohol level achieved before-after bariatric surgery and among bariatric surgery and control groups
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 in alcohol subjective effects from pre- to post- bariatric surgery and among bariatric surgery and control groups
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 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
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 in the rate of alcohol elimination between pre- and post-surgery and among the different bariatric surgery groups and the control groups.
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: Changes in alcohol's effects on glucose homeostasis [pre- to post-surgery and among bariatric surgery groups and control groups.
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: Changes in alcohol's effects on insulin [pre- to post-surgery and among bariatric surgery groups and control groups.
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: Changes in alcohol's effects on C-peptide [pre- to post-surgery and among bariatric surgery groups and control groups.
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: Changes in alcohol's effects on FGF21 [pre- to post-surgery and among bariatric surgery groups and control groups.
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: Changes in alcohol's effects on ghrelin [pre- to post-surgery and among bariatric surgery groups and control groups.
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: Changes in alcohol's effects on GLP-1 [pre- to post-surgery and among bariatric surgery groups and control groups.
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: Urbana
country: United States
facility: University of Illinois at Urbana Champaign
state: Illinois
Study officials:
affiliation: UIUC
name: Marta Y Pepino de Gruev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.soard.2020.01.014. Epub 2020 Jan 23.
citation: 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.
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.
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.