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CompletedNCT03475849Updated Mar 23, 2018

Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

An observational study in Obesity, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-23.

Sponsored by Hvidovre University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
25 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether the bile acid circulation is changed after gastric bypass surgery. Further, to account for how the changed anatomy of the gut influences how the bile acid and food is mixed in the gut and how this is associated with the changes in gut hormone release after the surgery.

Our hypothesis is that bile acid reabsorption from the gut is increased as animal models suggest so and bile acid blood concentration increases after surgery.

02

Conditions studied

  • Obesity

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Keywords

  • Roux-en-Y Gastric Bypass Surgery
  • Bile Acid Circulation
  • Obesity
  • Bariatric Surgery
03

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark) Controls are recruited from www.forsoegsperson.dk (Danish webpage for recruitment of trial persons). Controls are recruited by advertisement.

Inclusion criteria

  • Age between 25 and 65 years
  • For patients: uncomplicated Roux-en-Y Gastric Bypass surgery more than 12 months before study initiation
  • For controls: Age, BMI and gender matched with patient group

Exclusion criteria

Exclusion Criteria:

  • Previous removal of gall bladder or other abdominal surgeries except appendectomy (and gastric bypass surgery for patient group)
  • Known liver disease or thyroid disease requiring antithyroid medication
  • Chronic gastrointestinal symptoms
  • Any chronic disease interfering with, or susceptive of interfering with appetite or gastrointestinal function
  • Any medication interfering with, or susceptive of interfering with appetite or gastrointestinal function
  • Smoking within the last month
  • Alcohol consumption above 168 grams per week
  • Currently pregnant or breast-feeding
  • Anaemia with haemoglobin \<6,5 mmol/L (\<117 mg/dl)
  • Loss or gain of more than 3 kg within the last 3 months
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • RYGB subjects

    Morbidly obese patients who has undergone an uncomplicated gastric bypass surgery more than 12 months before study start.

  • Control subjects

    Age, sex and BMI-matched healthy controls

  • SG subjects

    Morbidly obese patients who has undergone an uncomplicated sleeve gastrectomy surgery more than 12 months before study start.

05

What researchers measure

Primary outcomes

  1. Differences in time from food intake to mix of food in the gut with bile acid between patients and controls

    Time frame: Patients: >12 months after Gastric Bypass Surgery

  2. Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days

    Time frame: Patients: >12 months after Gastric Bypass Surgery

06

Study locations

1 site
  • Department of Endocrinology at Hvidovre University Hospital
    Hvidovre, Copenhagen DK-2650, Denmark
07

Registry details

Key details

Study ID
NCT03475849
Lead sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
Responsible party
Carsten Dirksen (MD, PhD, Hvidovre University Hospital) — Principal investigator
First posted
Mar 23, 2018
Start date
Sep 2016
Primary completion
Jun 2017
Completion
Jun 2017
Last update
Mar 23, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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