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Bariatric Surgery and Alcohol Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Norwegian University of Science and Technology
Sponsor:
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: July 21, 2014
Last verified: July 2014
  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 2017
Estimated Primary Completion Date: November 2014 (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
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

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         
Terez Stokkan Recruiting
Trondheim, Norway, 7000
Contact: Magnus Strømmen         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Bård Kulseng, MD phd Norwegian University of Science and Technology
  More Information

No publications provided

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: July 21, 2014
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
Body Weight
Nutrition Disorders
Obesity
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014