Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

NCT ID: NCT03475849

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-06-30

Brief 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.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

RYGB subjects

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

No interventions assigned to this group

Control subjects

Age, sex and BMI-matched healthy controls

No interventions assigned to this group

SG subjects

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carsten Dirksen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Endocrinology at Hvidovre University Hospital

Hvidovre, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

GAL-CAJ-16

Identifier Type: -

Identifier Source: org_study_id