BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2016 by Norwegian University of Science and Technology
Sponsor:
Norwegian University of Science and Technology
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01840020
First received: April 15, 2013
Last updated: May 4, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity, Morbid |
Procedure: Gastric bypass Procedure: gastric sleeve |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Changes in Bioavailability of Ethanol Following Bariatric Surgery |
Resource links provided by NLM:
Further study details as provided by Norwegian University of Science and Technology:
Primary Outcome Measures:
- Change in bioavailability of ethanol [ Time Frame: from baseline to 3 months, 1 year, and 3 years ] [ Designated as safety issue: No ]
bioavailability tests: Plasma concentration of ethanol. Calculation:
- Area under curve (AUC)
- Maximum concentration(Cmax)
- Time up to maximum concentration (tmax)
- Oral bioavailability (AUCpo/AUCiv)
Biospecimen Retention: Samples Without DNA
blood samples
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Gastric bypass
patients recruited from Central Norway
|
Procedure: Gastric bypass
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 sleeve
patients recruited from Central Norway
|
Procedure: gastric sleeve
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- drugs that interact with alcohol dehydrogenase
- drugs that slow down emptying of the stomach
- pregnancy
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840020
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840020
Contacts
| Contact: Magnus Strømmen, MSc | (+47) 9170 1010 | magnus.strommen@stolav.no | |
| Contact: Bård Kulseng, PhD |
Locations
| Norway | |
| Sykehuset Namsos | Recruiting |
| Namsos, Norway | |
| Contact: Magnus Strømmen | |
| Obesity policlinic of St. Olavs Hospital | Recruiting |
| Trondheim, Norway | |
| Contact: Magnus Strømmen | |
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
| Principal Investigator: | Magnus Strommen, MSc | Norwegian University of Science and Technology |
More Information
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01840020 History of Changes |
| Other Study ID Numbers: | 2012/1206 |
| Study First Received: | April 15, 2013 |
| Last Updated: | May 4, 2016 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Norwegian University of Science and Technology:
|
bariatric surgery alcohol drinking alcoholism ethanol metabolism |
Additional relevant MeSH terms:
|
Obesity, Morbid Obesity Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016