ObesityNCT03475849
Effects of Gastric Bypass Surgery on Bile Acid Homeostasis
An observational study of Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology at Hvidovre University Hospital
Hvidovre, Copenhagen, DK-2650
About this study
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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in time from food intake to mix of food in the gut with bile acid between patients and controls
Measured: Patients: >12 months after Gastric Bypass Surgery
Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days
Measured: Patients: >12 months after Gastric Bypass Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startSep 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Carsten Dirksen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475849
- Sponsor's protocol ID
- GAL-CAJ-16
- Status last verified
- Mar 2018
- First submitted
- 18 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gastric Bypass Surgery on Bile Acid Homeostasis
- ClinicalTrials.gov ID
- NCT03475849
- Acronym / sponsor ID
- GAL-CAJ-16
- Conditions
- Obesity
- Keywords
- Roux-en-Y Gastric Bypass Surgery, Bile Acid Circulation, Obesity, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.