Obesity, MorbidNCT01840020
BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
An observational study of Obesity, Morbid, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass procedure, involves significant changes to the size and function of the stomach and leads to more rapid gastric emptying. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Gastric bypass and gastric sleeve
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2013to Feb 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway
Who may be able to join
- volunteers from Central Norway
- morbid obese BMI > 40 kg/m2)
- morbid obese BMI > 35 kg/m2 given a obesity related disease that qualifies for bariatric surgery
Who cannot join
- previous or current alcohol abuse
- risk for alcohol harm as assessed by AUDIT
- alcohol abstinence
- liver disease except fatty liver, which occurs in more than 50% of those who seek bariatric surgery
- previous colon resection
- not/insufficiently able to informed consent
Show all 9Show fewer
- drugs that interact with alcohol dehydrogenase
- drugs that slow down emptying of the stomach
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Sykehuset Namsos
Namsos
Obesity policlinic of St. Olavs Hospital
Trondheim
About this study
Official title: Changes in Bioavailability of Ethanol Following Bariatric Surgery
The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass procedure, involves significant changes to the size and function of the stomach and leads to more rapid gastric emptying. Consequences will be faster absorption and higher peak concentration of ethanol after surgery than before. There are growing concerns that surgery for obesity in this way may cause alcohol abuse.
In this study the investigators compare changes in FPM of ethanol following two different bariatric surgical procedures.
- Conditions
- Obesity, Morbid
- Being tested
- Gastric bypass, gastric sleeve
- Keywords
- bariatric surgery, alcohol drinking, alcoholism, ethanol, metabolism
- Medical subject headings
- Obesity, Morbid, Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Surgical procedure in which the stomach is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the small intestine by an end-to-side surgical anastomosis.
gastric sleeveProcedure or surgery
Sleeve gastrectomy, a surgical procedure in which the stomach is reduced to about 25% of its original size, by surgical removal of a large portion of the stomach, following the major curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube with a banana shape.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | patients recruited from Central Norway Receives: Procedure: Gastric bypass | |
| Gastric sleeve | patients recruited from Central Norway Receives: Procedure: gastric sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bioavailability of ethanol
bioavailability tests: Plasma concentration of ethanol. Calculation:
- Area under curve (AUC)
- Maximum concentration(Cmax)
- Time up to maximum concentration (tmax)
- Oral bioavailability (AUCpo/AUCiv)
Measured: from baseline to 3 months, 1 year, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2020
- Study completionFeb 2020
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 Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Magnus Strommen, MSc, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840020
- Sponsor's protocol ID
- 2012/1206
- Status last verified
- Feb 2020
- First submitted
- 15 Apr 2013
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strommen M, Dale O, Klockner C, Tylleskar I. Ethanol pharmacokinetics before and after sleeve gastrectomy and Roux-en-Y gastric bypass: a 3 year prospective study (the BAR-TRIAL). Int J Obes (Lond). 2026 Jul;50(7):1573-1580. doi: 10.1038/s41366-026-02113-3. Epub 2026 Jun 17.
PubMed 42310386
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bioavailability of Ethanol Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01840020
- Acronym / sponsor ID
- 2012/1206
- Conditions
- Obesity, Morbid
- Keywords
- bariatric surgery, alcohol drinking, alcoholism, ethanol, metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2013 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 25 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 first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass procedure, involves significant changes to the size and function of the stomach and leads to more rapid gastric emptying. Consequences will be faster absorption and higher peak concentration of ethanol after surgery than before. There are growing concerns that surgery for obesity in this way may cause alcohol abuse.
In this study the investigators compare changes in FPM of ethanol following two different bariatric surgical procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | – | Procedure: Gastric bypasspatients recruited from Central Norway |
| Gastric sleeve | – | Procedure: gastric sleevepatients recruited from Central Norway |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway
Key inclusion criteria (3 listed)
- volunteers from Central Norway
- morbid obese BMI > 40 kg/m2)
- morbid obese BMI > 35 kg/m2 given a obesity related disease that qualifies for bariatric surgery
Key exclusion criteria (9 listed)
- previous or current alcohol abuse
- risk for alcohol harm as assessed by AUDIT
- alcohol abstinence
- liver disease except fatty liver, which occurs in more than 50% of those who seek bariatric surgery
- previous colon resection
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 |
|---|---|---|
| Gastric bypassSurgical procedure in which the stomach is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the small intestine by an end-to-side surgical anastomosis. | Procedure or surgery | Gastric bypass |
| gastric sleeveSleeve gastrectomy, a surgical procedure in which the stomach is reduced to about 25% of its original size, by surgical removal of a large portion of the stomach, following the major curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube with a banana shape. | Procedure or surgery | Gastric sleeve |
Primary outcome
Change in bioavailability of ethanol
Time frame: from baseline to 3 months, 1 year, and 3 years
bioavailability tests: Plasma concentration of ethanol. Calculation: * Area under curve (AUC) * Maximum concentration(Cmax) * Time up to maximum concentration (tmax) * Oral bioavailability (AUCpo/AUCiv)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 42310386Strommen M, Dale O, Klockner C, Tylleskar I. Ethanol pharmacokinetics before and after sleeve gastrectomy and Roux-en-Y gastric bypass: a 3 year prospective study (the BAR-TRIAL). Int J Obes (Lond). 2026 Jul;50(7):1573-1580. doi: 10.1038/s41366-026-02113-3. Epub 2026 Jun 17.
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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.
Magnus Strommen, MSc principal investigator
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Norwegian University of Science and Technology at 2 sites in Norway.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 bioavailability of ethanol (time frame: from baseline to 3 months, 1 year, and 3 years). 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 NCT01840020, 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 26 Feb 2020.