Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

NCT03475849 | Completed

• 1 other identifier: GAL-CAJ-16
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

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

  Patients: >12 months after Gastric Bypass Surgery

Study Arms (3)

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.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Endocrinology at Hvidovre University Hospital

Hvidovre, Copenhagen, DK-2650, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 23, 2018
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

DK (1)