NCT02766322

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

6.2 years

First QC Date

April 27, 2016

Last Update Submit

March 7, 2025

Conditions

Obesity

Keywords

Alcohol metabolismBariatric surgery

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (6)

  • Changes in alcohol's effects on glucose homeostasis [pre- to post-surgery and among bariatric surgery groups 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.

  • Changes in alcohol's effects on insulin [pre- to post-surgery and among bariatric surgery groups 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.

  • Changes in alcohol's effects on C-peptide [pre- to post-surgery and among bariatric surgery groups 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.

  • Changes in alcohol's effects on FGF21 [pre- to post-surgery and among bariatric surgery groups 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.

  • Changes in alcohol's effects on ghrelin [pre- to post-surgery and among bariatric surgery groups 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.

  • +1 more secondary outcomes

Study Arms (7)

Gastric Bypass longitudinal

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.

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

Gastric Banding longitudinal

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.

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

Sleeve gastrectomy longitudinal

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..

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

Gastric Bypass (cross-sectional)

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.

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

Gastric Banding (cross-sectional)

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.

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

Sleeve gastrectomy (cross-sectional)

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.

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

Non-surgical group

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.

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

Interventions

Oral Alcohol challenge test Alcohol visit firstOTHER

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).

Gastric Banding (cross-sectional)Gastric Banding longitudinalGastric Bypass (cross-sectional)Gastric Bypass longitudinalNon-surgical groupSleeve gastrectomy (cross-sectional)Sleeve gastrectomy longitudinal
Oral Alcohol challenge test Placebo visit firstOTHER

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).

Gastric Banding (cross-sectional)Gastric Banding longitudinalGastric Bypass (cross-sectional)Gastric Bypass longitudinalNon-surgical groupSleeve gastrectomy (cross-sectional)Sleeve gastrectomy longitudinal
Intravenous Alcohol Challenge Test (Clamp)OTHER

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.

Gastric Banding (cross-sectional)Gastric Banding longitudinalGastric Bypass (cross-sectional)Gastric Bypass longitudinalNon-surgical groupSleeve gastrectomy (cross-sectional)Sleeve gastrectomy longitudinal
Intravenous Alcohol Self-administration TestOTHER

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.

Gastric Banding (cross-sectional)Gastric Banding longitudinalGastric Bypass (cross-sectional)Gastric Bypass longitudinalNon-surgical groupSleeve gastrectomy (cross-sectional)Sleeve gastrectomy longitudinal

Eligibility Criteria

Age21 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Bariatric surgery clinic

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (6)

  • 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.

    PMID: 35315921BACKGROUND

  • 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.

    PMID: 32075778BACKGROUND

  • 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.

    PMID: 29305304BACKGROUND

  • 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.

    PMID: 36871954BACKGROUND

  • 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.

    PMID: 37407434BACKGROUND

  • Molina-Castro M, Rowitz B, Pepino MY. Glucagon-like peptide-1, fibroblast growth factor 21, and other endocrine responses to alcohol ingestion in women before and after metabolic surgery. Front Pharmacol. 2025 May 22;16:1575156. doi: 10.3389/fphar.2025.1575156. eCollection 2025.

    PMID: 40474966DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Plasma

MeSH Terms

Conditions

Obesity

Interventions

EthanolConstriction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Study Officials

  • Marta Y Pepino de Gruev, PhD

    UIUC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 9, 2016

Study Start

March 1, 2016

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

US(1)