ObesityRBANCT01843257
Effects of Alcohol After Bariatric Surgery
An observational study of Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Alcohol challenge test Alcohol visit first
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Sep 2021
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bariatric surgery clinic
Who may be able to join
- Women
- Drink alcohol at least once per month
Who cannot join
- Men
- Drinks more than 7 standard drinks per week or more than 4 standard drinks in a period of 2 hours for the month before enrolling in the study.
- Regular use of drugs of abuse or use of any medication interacting with alcohol pharmacokinetics or pharmacologic effects.
- Alcohol dependence
- Pregnancy, lactation or not using effective methods of birth control
- Smoking
- Anemia
- Liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana Champaign
St Louis, Missouri, 63110
About this study
Official title: Pharmacokinetics and Pharmacological Effects of Alcohol After Bariatric Surgery
The investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. 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 blood sugar; and 3) the effects of alcohol on mood.
Read the detailed description
The study includes seven groups of women: One group will be undergoing gastric bypass, another group will be undergoing lap banding, a third group will be undergoing sleeve gastrectomy, the fourth group will be women who underwent gastric bypass 1-5 years ago, the fifth group will be women who underwent lap banding 1-5 years ago, the sixth group will be women who underwent sleeve gastrectomy 1-5 years ago, and the seventh group will be a control group who have not undergone bariatric surgery.
- Conditions
- Obesity
- Being tested
- Alcohol challenge test Alcohol visit first, Alcohol challenge test Placebo visit first
- Keywords
- Alcohol intake after bariatric surgery, Alcohol and 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.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass longitudinal | Morbidly obese subjects undergoing gastric bypass surgery. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery. Receives: Other: Alcohol challenge test Alcohol visit first; Other: Alcohol challenge test Placebo visit first | |
| Gastric Banding longitudinal | Morbidly obese subjects undergoing laparoscopic gastric banding surgery. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery. Receives: Other: Alcohol challenge test Alcohol visit first; Other: Alcohol challenge test Placebo visit first | |
| Gastric Bypass (cross-sectional) | Subjects who underwent gastric bypass surgery 1-5 years ago. 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 before surgery. Receives: Other: Alcohol challenge test Alcohol visit first; Other: Alcohol challenge test Placebo visit first | |
| Gastric Banding (cross-sectional) | Subjects who underwent gastric banding surgery 1-5 years ago. 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 before surgery. Receives: Other: Alcohol challenge test Alcohol visit first; Other: Alcohol challenge test Placebo visit first | |
| Sleeve gastrectomy (longitudinal) | Morbidly obese subjects who will undergo sleeve gastrectomy. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery. Receives: Other: Alcohol challenge test Alcohol visit first; Other: Alcohol challenge test Placebo visit first | |
| Sleeve gastrectomy (cross-sectional) | Subjects who underwent sleeve gastrectomy 1-5 years ago. 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 before surgery. Receives: Other: Alcohol challenge test Alcohol visit first; Other: Alcohol challenge test Placebo visit first | |
| No bariatric surgery control | Control group of women with age and BMI similar to those in the cross-sectional arm of the study who have not undergone bariatric surgery.
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 before surgery. Receives: Other: Alcohol challenge test Alcohol visit first; Other: Alcohol challenge test Placebo visit first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from before bariatric surgery in alcohol's Tmax, Cmax, area under the curve and elimination rates at approximately 9 months after bariatric surgery
Time to reach maximum peak blood alcohol levels, alcohol area under the time-concentration curve and alcohol's constant of elimination will be examined before and after surgery and compared between those who had gastric bypass versus lap banding.
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 from before bariatric surgery in alcohol subjective effects at approximately 9 months after bariatric surgery
Validated instruments (such as the Addiction Research Center Inventory) will be used to measured alcohol's subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage.
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 (1)
Change from before bariatric surgery on alcohol's effects on glucose homeostasis at approximately 9 months after bariatric surgery
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.
- First posted30 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Y Pepino, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843257
- Sponsor's protocol ID
- NCT01843257
- Acronym
- RBA
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2013
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pepino MY, Okunade AL, Eagon JC, Bartholow BD, Bucholz K, Klein S. Effect of Roux-en-Y Gastric Bypass Surgery: Converting 2 Alcoholic Drinks to 4. JAMA Surg. 2015 Nov;150(11):1096-8. doi: 10.1001/jamasurg.2015.1884. No abstract available.
PubMed 26244751
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacological Effects of Alcohol After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01843257
- Acronym / sponsor ID
- RBA / NCT01843257
- Conditions
- Obesity
- Keywords
- Alcohol intake after bariatric surgery, Alcohol and bariatric surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia, Washington University School of Medicine
- Study start
- Apr 2013
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 30 Apr 2013 (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.
The investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. 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 blood sugar; and 3) the effects of alcohol on mood.
Detailed description
The study includes seven groups of women: One group will be undergoing gastric bypass, another group will be undergoing lap banding, a third group will be undergoing sleeve gastrectomy, the fourth group will be women who underwent gastric bypass 1-5 years ago, the fifth group will be women who underwent lap banding 1-5 years ago, the sixth group will be women who underwent sleeve gastrectomy 1-5 years ago, and the seventh group will be a control group who have not undergone bariatric surgery.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass longitudinal | – | Other: Alcohol challenge test Alcohol visit first, Other: Alcohol challenge test Placebo visit firstMorbidly obese subjects undergoing gastric bypass surgery. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery. |
| Gastric Banding longitudinal | – | Other: Alcohol challenge test Alcohol visit first, Other: Alcohol challenge test Placebo visit firstMorbidly obese subjects undergoing laparoscopic gastric banding surgery. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery. |
| Gastric Bypass (cross-sectional) | – | Other: Alcohol challenge test Alcohol visit first, Other: Alcohol challenge test Placebo visit firstSubjects who underwent gastric bypass surgery 1-5 years ago. 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 before surgery. |
| Gastric Banding (cross-sectional) | – | Other: Alcohol challenge test Alcohol visit first, Other: Alcohol challenge test Placebo visit firstSubjects who underwent gastric banding surgery 1-5 years ago. 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 before surgery. |
| Sleeve gastrectomy (longitudinal) | – | Other: Alcohol challenge test Alcohol visit first, Other: Alcohol challenge test Placebo visit firstMorbidly obese subjects who will undergo sleeve gastrectomy. 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 before surgery. The two testing sessions will be repeated ~ 9 months after surgery. |
| Sleeve gastrectomy (cross-sectional) | – | Other: Alcohol challenge test Alcohol visit first, Other: Alcohol challenge test Placebo visit firstSubjects who underwent sleeve gastrectomy 1-5 years ago. 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 before surgery. |
| No bariatric surgery control | – | Other: Alcohol challenge test Alcohol visit first, Other: Alcohol challenge test Placebo visit firstControl group of women with age and BMI similar to those in the cross-sectional arm of the study who have not undergone bariatric surgery. 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 before surgery. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bariatric surgery clinic
Key inclusion criteria (2 listed)
- Women
- Drink alcohol at least once per month
Key exclusion criteria (8 listed)
- Men
- Drinks more than 7 standard drinks per week or more than 4 standard drinks in a period of 2 hours for the month before enrolling in the study.
- Regular use of drugs of abuse or use of any medication interacting with alcohol pharmacokinetics or pharmacologic effects.
- Alcohol dependence
- Pregnancy, lactation or not using effective methods of birth control
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 |
|---|---|---|
| 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, No bariatric surgery control, Sleeve gastrectomy (cross-sectional), Sleeve gastrectomy (longitudinal) |
| 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, No bariatric surgery control, Sleeve gastrectomy (cross-sectional), Sleeve gastrectomy (longitudinal) |
Primary outcome
Change from before bariatric surgery in alcohol's Tmax, Cmax, area under the curve and elimination rates at approximately 9 months after bariatric surgery
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 maximum peak blood alcohol levels, alcohol area under the time-concentration curve and alcohol's constant of elimination will be examined before and after surgery and compared between those who had gastric bypass versus lap banding.
Change from before bariatric surgery in alcohol subjective effects at approximately 9 months after bariatric surgery
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) will be used to measured alcohol's subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage.
1 secondary outcome
Change from before bariatric surgery on alcohol's effects on glucose homeostasis at approximately 9 months after bariatric surgery
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 26244751Pepino MY, Okunade AL, Eagon JC, Bartholow BD, Bucholz K, Klein S. Effect of Roux-en-Y Gastric Bypass Surgery: Converting 2 Alcoholic Drinks to 4. JAMA Surg. 2015 Nov;150(11):1096-8. doi: 10.1001/jamasurg.2015.1884. No abstract available.
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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, PhD principal investigator
University of Illinois at Urbana-Champaign
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. 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?
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 from before bariatric surgery in alcohol's Tmax, Cmax, area under the curve and elimination rates at approximately 9 months after bariatric surgery (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 2 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 NCT01843257, which also lists 1 linked publication.
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 27 Apr 2021.