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BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01840020
Recruitment Status : Active, not recruiting
First Posted : April 25, 2013
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date April 15, 2013
First Posted Date April 25, 2013
Last Update Posted Date March 13, 2019
Actual Study Start Date September 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2013)
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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01840020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Official Title Changes in Bioavailability of Ethanol Following Bariatric Surgery
Brief 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. 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood samples
Sampling Method Non-Probability Sample
Study Population persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway
Condition Obesity, Morbid
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • Gastric bypass
    patients recruited from Central Norway
    Intervention: Procedure: Gastric bypass
  • Gastric sleeve
    patients recruited from Central Norway
    Intervention: Procedure: gastric sleeve
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 22, 2013)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01840020
Other Study ID Numbers 2012/1206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor Norwegian University of Science and Technology
Collaborators St. Olavs Hospital
Investigators
Principal Investigator: Magnus Strommen, MSc Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date March 2019