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Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

H

Hvidovre University Hospital

Status

Completed

Conditions

Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT03475849
GAL-CAJ-16

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

  • 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

Trial design

40 participants in 3 patient groups

RYGB subjects
Description:
Morbidly obese patients who has undergone an uncomplicated gastric bypass surgery more than 12 months before study start.
Control subjects
Description:
Age, sex and BMI-matched healthy controls
SG subjects
Description:
Morbidly obese patients who has undergone an uncomplicated sleeve gastrectomy surgery more than 12 months before study start.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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