Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03475849

Enrollment

Registered

2018-03-23

Start date

2016-09-30

Completion date

2017-06-30

Last updated

2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Denmark

Outcome results