Bileacid MalabsorptionPhase 4NCT03009916
Bileacid Malabsorption and GLP-1 Secretion
A Phase 4 study testing "cholestagel®" (Colesevelam) in people with Bileacid Malabsorption, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bileacid Malabsorption
- What is being tested?
- "cholestagel®" (Colesevelam)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to 4 Aug 2017
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Northern European origin
- Normal haemoglobin
- Age above 18 years and below 70 years
- Informed and written consent
- BMI > 23 kg/m2 and < 35 kg/m2
- Normal fasting plasma glucose (FPG) < 6.5 mM) and glycated haemoglobin (HbA1c) < 48 mmol/mol
Who cannot join
- Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- First-degree relatives with diabetes
- Nephropathy (serum creatinine >150 µM and/or albuminuria
- Treatment with medicine that cannot be paused for 12 hours
- Hypothyroidism or hyperthyroidism
Show all 11Show fewer
- Treatment with oral anticoagulants
- Active or recent malignant disease
- Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- Lack of effective birth control in premenopausal women
- Any condition considered incompatible with participation by the investigators
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration.
- Conditions
- Bileacid Malabsorption
- Being tested
- "cholestagel®" (Colesevelam), Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"cholestagel®" (Colesevelam)Drug
3750mg
PlacebosDrug
3750mg
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | Healthy controls found according to the protocol Receives: Drug: "cholestagel®" (Colesevelam); Drug: Placebos |
| Patients with BAM | Other | Patients with bile acid malabsorption found according to the protocol Receives: Drug: "cholestagel®" (Colesevelam); Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startMar 2016
- Primary completion3 Aug 2017
- Study completion4 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bileacid MalabsorptionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009916
- Sponsor's protocol ID
- H-15004394
- Status last verified
- Aug 2017
- First submitted
- 21 Dec 2016
- Last updated
- 7 Aug 2017
- Results posted
- No
Publications
Karhus ML, Sonne DP, Thomasen M, Ellegaard AM, Holst JJ, Rehfeld JF, Chavez-Talavera O, Tailleux A, Staels B, Nielsen DS, Krych L, Dragsted LO, Vilsboll T, Bronden A, Knop FK. Enterohepatic, Gluco-metabolic, and Gut Microbial Characterization of Individuals With Bile Acid Malabsorption. Gastro Hep Adv. 2022 Mar 30;1(3):299-312. doi: 10.1016/j.gastha.2021.12.007. eCollection 2022.
PubMed 39131668
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bileacid Malabsorption and GLP-1 Secretion
- ClinicalTrials.gov ID
- NCT03009916
- Acronym / sponsor ID
- H-15004394
- Conditions
- Bileacid Malabsorption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 4 Jan 2017 (estimated)
- 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 aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Other | Drug: "cholestagel®" (Colesevelam), Drug: PlacebosHealthy controls found according to the protocol |
| Patients with BAM | Other | Drug: "cholestagel®" (Colesevelam), Drug: PlacebosPatients with bile acid malabsorption found according to the protocol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Northern European origin
- Normal haemoglobin
- Age above 18 years and below 70 years
- Informed and written consent
- BMI > 23 kg/m2 and < 35 kg/m2
Key exclusion criteria (11 listed)
- Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- First-degree relatives with diabetes
- Nephropathy (serum creatinine >150 µM and/or albuminuria
- Treatment with medicine that cannot be paused for 12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "cholestagel®" (Colesevelam)3750mg | Drug | Healthy controls, Patients with BAM |
| Placebos3750mg | Drug | Healthy controls, Patients with BAM |
Primary outcome
GLP-1
Time frame: 240 min
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 7 Aug 2017.
- Derived from this study: PubMed 39131668Karhus ML, Sonne DP, Thomasen M, Ellegaard AM, Holst JJ, Rehfeld JF, Chavez-Talavera O, Tailleux A, Staels B, Nielsen DS, Krych L, Dragsted LO, Vilsboll T, Bronden A, Knop FK. Enterohepatic, Gluco-metabolic, and Gut Microbial Characterization of Individuals With Bile Acid Malabsorption. Gastro Hep Adv. 2022 Mar 30;1(3):299-312. doi: 10.1016/j.gastha.2021.12.007. eCollection 2022.
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?
A Phase 4 study testing "cholestagel®" (Colesevelam) in people with Bileacid Malabsorption, run by University Hospital, Gentofte, Copenhagen 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 6 inclusion and 11 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 7 Aug 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
GLP-1 (time frame: 240 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009916, which also lists 1 linked publication.
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 7 Aug 2017.