Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475849
• Other study ID #: GAL-CAJ-16
• Status: Completed
• First received: March 18, 2018
• Last updated: March 18, 2018
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2018
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Denmark	Department of Endocrinology at Hvidovre University Hospital	Hvidovre	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in time from food intake to mix of food in the gut with bile acid between patients and controls		Patients: >12 months after Gastric Bypass Surgery
Primary	Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days		Patients: >12 months after Gastric Bypass Surgery