Bariatric Surgery CandidateEarly Phase 1Bile-barNCT06925997
Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
A Early Phase 1 study testing Colesevelam in people with Bariatric Surgery Candidate and Bile Acid, Elevated Serum, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Bile Acid, Elevated Serum, Glucose Metabolism Disorders
- What is being tested?
- Colesevelam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 2 May 2024to Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intervention group
- RYGB-operated ≥ 18 months prior to inclusion
- History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
- HbA1c <58 mmol/mol on no antidiabetic medication or metformin alone
- Weight change < ±3 kg for >3 months at time of inclusion
- Control group A
Show all 12Show fewer
- No history of diabetes
- HbA1c <48 mmol/mol at time of inclusion
- Fasting plasma glucose < 7.0 mmol/L at time of inclusion
- Weight change < ±3 kg for >3 months at time of inclusion Control group B
- Type 2 diabetes (HbA1c ≥48 mmol/mol or use of antidiabetic medication at time of inclusion)
- Weight change < ±3 kg for >3 months at time of inclusion
Who cannot join
- Pregnancy or breastfeeding
- Haemoglobin < 6.5 mmol/L at time of inclusion
- Fasting plasma glucose > 10.0 mmol/L at time of inclusion
- Prior cholecystectomy
- Chronic or tendency to diarrhoea
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carsten Dirksen contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, 2650
Marie-Louise Dichman, +4526710371, marie-louise.dichman@regionh.dk
Carsten Dirksen, carsten.dirksen@regionh.dk
About this study
Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).
Read the detailed description
The study design consists of 4 study visits, two performed before (V1 at day -7 and V2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatment (V3 at day 49 and V4 at day 56). Biometrics, fasting blood samples and a standard mixed meal test are performed at V2 and V4. 75Se-HCAT scintigraphy is carried out between V1 to V2 and V3 to V4, respectively. Between V2 and V3 the subjects will have two telephone calls and one visit at the Endocrine Research Unit for fasting blood samples to make sure they do not experience any adverse events and are compliant.
The control groups will only participate in V1 and V2. The aim with the control groups is to have baseline values for unoperated subjects with and without diabetes to compare with the values in the intervention group after 8 weeks of depletion of endogenous bile acids.
- Being tested
- Colesevelam
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColesevelamDrug
Colesevelam is an approved drug with well known adverse events. Gastrointestinal side effects (Obstipation, flatulence, abdominal pain, diarrhea, nausea, meteorism, vomiting, chanced faeces) are very common (>10%) or common (1-10%), but are mild and tolerable in most cases. All participants will be monitored closely, and colesevelam will be discontinued if the subject experience unreserved adverse events. All effects of colesevelam are transient (17-19) as the compound is not absorbed to the systemic circulation, i.e. treatment effects cease when the drug is excreted from the intestine. Specifically, no permanent metabolic effects of colesevelam has been observed in crossover experiments (27). Therefore, 8 weeks of colesevelam treatment as planned in the current study will have no long lasting positive or negative effects on the participants.
| Study group | Role | What they receive |
|---|---|---|
| 3.75 mg Colesevelam in 8 weeks | Experimental | Not described Receives: Drug: Colesevelam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Changes in total areal under the curve (AUC) of plasma glucose concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Measured: 8 weeks
FGF-19
Changes in total AUC of plasma FGF-19 concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start2 May 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Louise Dichman, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925997
- Sponsor's protocol ID
- H-22041713
- Acronym
- Bile-bar
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT06925997
- Acronym / sponsor ID
- Bile-bar / H-22041713
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Apr 2025 (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.
Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).
Detailed description
The study design consists of 4 study visits, two performed before (V1 at day -7 and V2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatment (V3 at day 49 and V4 at day 56). Biometrics, fasting blood samples and a standard mixed meal test are performed at V2 and V4. 75Se-HCAT scintigraphy is carried out between V1 to V2 and V3 to V4, respectively. Between V2 and V3 the subjects will have two telephone calls and one visit at the Endocrine Research Unit for fasting blood samples to make sure they do not experience any adverse events and are compliant.
The control groups will only participate in V1 and V2. The aim with the control groups is to have baseline values for unoperated subjects with and without diabetes to compare with the values in the intervention group after 8 weeks of depletion of endogenous bile acids.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3.75 mg Colesevelam in 8 weeks | Experimental | Drug: Colesevelam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Intervention group
- RYGB-operated ≥ 18 months prior to inclusion
- History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
- HbA1c <58 mmol/mol on no antidiabetic medication or metformin alone
- Weight change < ±3 kg for >3 months at time of inclusion
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Haemoglobin < 6.5 mmol/L at time of inclusion
- Fasting plasma glucose > 10.0 mmol/L at time of inclusion
- Prior cholecystectomy
- Chronic or tendency to diarrhoea
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 |
|---|---|---|
| ColesevelamColesevelam is an approved drug with well known adverse events. Gastrointestinal side effects (Obstipation, flatulence, abdominal pain, diarrhea, nausea, meteorism, vomiting, chanced faeces) are very common (>10%) or common (1-10%), but are mild and tolerable in most cases. All participants will be monitored closely, and colesevelam will be discontinued if the subject experience unreserved adverse events. All effects of colesevelam are transient (17-19) as the compound is not absorbed to the systemic circulation, i.e. treatment effects cease when the drug is excreted from the intestine. Specifically, no permanent metabolic effects of colesevelam has been observed in crossover experiments (27). Therefore, 8 weeks of colesevelam treatment as planned in the current study will have no long lasting positive or negative effects on the participants. | Drug | 3.75 mg Colesevelam in 8 weeks |
Primary outcome
Glucose
Time frame: 8 weeks
Changes in total areal under the curve (AUC) of plasma glucose concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
FGF-19
Time frame: 8 weeks
Changes in total AUC of plasma FGF-19 concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Carsten Dirksen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Colesevelam in people with Bariatric Surgery Candidate and Bile Acid, Elevated Serum, 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 12 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Louise Dichman (+4526710371, marie-louise.dichman@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (time frame: 8 weeks). 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 13 Apr 2025.