Skip to main content
OpenTrials
Completed

NCT Number: NCT03475849

Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology at Hvidovre University Hospital

Hvidovre, Copenhagen, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2018
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.