NCT01840020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

6.4 years

First QC Date

April 15, 2013

Last Update Submit

February 25, 2020

Conditions

Obesity, Morbid

Keywords

bariatric surgeryalcohol drinkingalcoholismethanolmetabolism

Outcome Measures

Primary Outcomes (1)

  • 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)

    from baseline to 3 months, 1 year, and 3 years

Study Arms (2)

Gastric bypass

patients recruited from Central Norway

Procedure: Gastric bypass

Gastric sleeve

patients recruited from Central Norway

Procedure: gastric sleeve

Interventions

Gastric bypassPROCEDURE

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 bypass
gastric sleevePROCEDURE

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.

Gastric sleeve

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sykehuset Namsos

Namsos, Norway

Location

Obesity policlinic of St. Olavs Hospital

Trondheim, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Obesity, MorbidAlcohol DrinkingAlcoholism

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDrinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Magnus Strommen, MSc

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 25, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

NO(2)