ObesityABSNCT02766322

Alcohol and Bariatric Surgery

An observational study of Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Oral Alcohol challenge test Alcohol visit first, Intravenous Alcohol Challenge Test (Clamp) and Intravenous Alcohol Self-administration Test
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Mar 2016to 25 May 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 64 years
Women only
Healthy volunteers accepted
Adult

Study population: Bariatric surgery clinic

Who may be able to join

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)

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Illinois at Urbana Champaign
Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery

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.

Read the 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).

Conditions: Obesity
Being tested: Oral Alcohol challenge test Alcohol visit first, Oral Alcohol challenge test Placebo visit first, Intravenous Alcohol Challenge Test (Clamp), Intravenous Alcohol Self-administration Test
Keywords: Alcohol metabolism, Bariatric surgery
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).
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).
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.
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.

Study groups in NCT02766322
Study group	Role	What they receive
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. Receives: Other: Oral Alcohol challenge test Alcohol visit first; Other: Oral Alcohol challenge test Placebo visit first; Other: 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. Receives: Other: Oral Alcohol challenge test Alcohol visit first; Other: Oral Alcohol challenge test Placebo visit first; Other: 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.. Receives: Other: Oral Alcohol challenge test Alcohol visit first; Other: Oral Alcohol challenge test Placebo visit first; Other: 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. Receives: Other: Oral Alcohol challenge test Alcohol visit first; Other: Oral Alcohol challenge test Placebo visit first; Other: 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. Receives: Other: Oral Alcohol challenge test Alcohol visit first; Other: Oral Alcohol challenge test Placebo visit first; Other: 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. Receives: Other: Oral Alcohol challenge test Alcohol visit first; Other: Oral Alcohol challenge test Placebo visit first; Other: 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. Receives: Other: Oral Alcohol challenge test Alcohol visit first; Other: Oral Alcohol challenge test Placebo visit first; Other: Intravenous Alcohol Challenge Test (Clamp); Other: Intravenous Alcohol Self-administration Test

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
mmol/L
Measured: 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.
pmol/L
Measured: 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.
nmol/L
Measured: 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.
pg/ml
Measured: 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.
pg/ml
Measured: 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 GLP-1 [pre- to post-surgery and among bariatric surgery groups and control groups.
pmol/L
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201625 May 2022

First posted9 May 2016 (estimated)
Study startMar 2016
Primary completion25 May 2022
Study completion25 May 2022

Why it stopped: Recruitment affected by COVID, then grant ended

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02766322
Sponsor's protocol ID: 16135
Other IDs: 17205
Acronym: ABS
Status last verified: Mar 2025
First submitted: 27 Apr 2016
Last updated: 11 Mar 2025
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 35315921
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.
PubMed 36871954
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.
PubMed 37407434
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.
PubMed 32075778
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.
PubMed 29305304
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.
PubMed 40474966

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery
ClinicalTrials.gov ID: NCT02766322
Acronym / sponsor ID: ABS / 16135
Conditions: Obesity
Keywords: Alcohol metabolism, Bariatric surgery
Study type: Observational
Recruitment status: TerminatedReason stopped: Recruitment affected by COVID, then grant ended
Enrolment: 54 participants (actual)
Lead sponsor: University of Illinois at Urbana-ChampaignUniversity, hospital or other
Collaborators: Carle Foundation Hospital
Study start: Mar 2016 (actual)
Primary completion: 25 May 2022 (actual)
Study completion: 25 May 2022 (actual)
First posted: 9 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Other
Number of arms: 7

Arm	Type	Receives
Gastric Bypass longitudinal	–	Other: Oral Alcohol challenge test Alcohol visit first, Other: Oral Alcohol challenge test Placebo visit first, Other: Intravenous Alcohol Challenge Test (Clamp), Other: Intravenous Alcohol Self-administration TestMorbidly 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.
Gastric Banding longitudinal	–	Other: Oral Alcohol challenge test Alcohol visit first, Other: Oral Alcohol challenge test Placebo visit first, Other: Intravenous Alcohol Challenge Test (Clamp), Other: Intravenous Alcohol Self-administration TestMorbidly 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.
Sleeve gastrectomy longitudinal	–	Other: Oral Alcohol challenge test Alcohol visit first, Other: Oral Alcohol challenge test Placebo visit first, Other: Intravenous Alcohol Challenge Test (Clamp), Other: Intravenous Alcohol Self-administration TestMorbidly 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..
Gastric Bypass (cross-sectional)	–	Other: Oral Alcohol challenge test Alcohol visit first, Other: Oral Alcohol challenge test Placebo visit first, Other: Intravenous Alcohol Challenge Test (Clamp), Other: Intravenous Alcohol Self-administration TestSubjects 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.
Gastric Banding (cross-sectional)	–	Other: Oral Alcohol challenge test Alcohol visit first, Other: Oral Alcohol challenge test Placebo visit first, Other: Intravenous Alcohol Challenge Test (Clamp), Other: Intravenous Alcohol Self-administration TestSubjects 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.
Sleeve gastrectomy (cross-sectional)	–	Other: Oral Alcohol challenge test Alcohol visit first, Other: Oral Alcohol challenge test Placebo visit first, Other: Intravenous Alcohol Challenge Test (Clamp), Other: Intravenous Alcohol Self-administration TestSubjects 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.
Non-surgical group	–	Other: Oral Alcohol challenge test Alcohol visit first, Other: Oral Alcohol challenge test Placebo visit first, Other: Intravenous Alcohol Challenge Test (Clamp), Other: Intravenous Alcohol Self-administration TestSubjects 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.

Who may qualify

Ages: 21 to 64 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Bariatric surgery clinic

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (6 listed)

Male
Smoker or quit < 6 months ago
Anemia
Liver disease
Body weight > 450 pounds

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral Alcohol challenge test Alcohol visit firstSubjects 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).	Other	Gastric Banding (cross-sectional), Gastric Banding longitudinal, Gastric Bypass (cross-sectional), Gastric Bypass longitudinal, Non-surgical group, Sleeve gastrectomy (cross-sectional), Sleeve gastrectomy longitudinal
Oral Alcohol challenge test Placebo visit firstSubjects 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).	Other	Gastric Banding (cross-sectional), Gastric Banding longitudinal, Gastric Bypass (cross-sectional), Gastric Bypass longitudinal, Non-surgical group, Sleeve gastrectomy (cross-sectional), Sleeve gastrectomy longitudinal
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.	Other	Gastric Banding (cross-sectional), Gastric Banding longitudinal, Gastric Bypass (cross-sectional), Gastric Bypass longitudinal, Non-surgical group, Sleeve gastrectomy (cross-sectional), Sleeve gastrectomy longitudinal
Intravenous Alcohol Self-administration TestSubjects 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.	Other	Gastric Banding (cross-sectional), Gastric Banding longitudinal, Gastric Bypass (cross-sectional), Gastric Bypass longitudinal, Non-surgical group, Sleeve gastrectomy (cross-sectional), Sleeve gastrectomy longitudinal

Primary outcome

Change in the peak blood alcohol level achieved before-after bariatric surgery and among bariatric surgery and control groups
Time frame: 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.
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.
Change in alcohol subjective effects from pre- to post- bariatric surgery and among bariatric surgery and control groups
Time frame: 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.
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
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
Time frame: 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.
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.
Change in the rate of alcohol elimination between pre- and post-surgery and among the different bariatric surgery groups and the control groups.
Time frame: 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.
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

6 secondary outcomes

Changes in alcohol's effects on glucose homeostasis [pre- to post-surgery and among bariatric surgery groups and control groups.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 GLP-1 [pre- to post-surgery and among bariatric surgery groups and control groups.
Time frame: 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.

Results and safety

The study was stopped early (reason given: Recruitment affected by COVID, then grant ended). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Background: PubMed 35315921Seyedsadjadi 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.
Background: PubMed 36871954Seyedsadjadi 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.
Background: PubMed 37407434Seyedsadjadi 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.
Results publication: PubMed 32075778Acevedo 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.
Results publication: PubMed 29305304Acevedo 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.
Derived from this study: PubMed 40474966Molina-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.
Individual participant dataSharing planned: Undecided

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Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marta Y Pepino de Gruev, PhD principal investigator

UIUC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment affected by COVID, then grant ended). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the peak blood alcohol level achieved before-after bariatric surgery and among bariatric surgery and control groups (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02766322, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.