Severe ObesityPhase 4NCT02952963
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
A Phase 4 study testing Chenodeoxycholic Acid and Colesevelam in people with Severe Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Chenodeoxycholic Acid and Colesevelam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Uncomplicated RYGB performed minimum 3 months prior to the study.
- Fasting glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB
Who cannot join
- Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB
- Dysregulated thyroid diseases, use of antithyroid treatment.
- Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
- Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake)
- Cholecystectomy.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.
- Conditions
- Severe Obesity
- Being tested
- Chenodeoxycholic Acid, Colesevelam
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chenodeoxycholic AcidDrug
ColesevelamDrug
| Study group | Role | What they receive |
|---|---|---|
| Chenodeoxycholic Acid | Experimental | Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water. Receives: Drug: Chenodeoxycholic Acid |
| Chenodeoxycholic Acid and Colesevelam | Experimental | Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water. Receives: Drug: Chenodeoxycholic Acid; Drug: Colesevelam |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 secretion (evaluated by iAUC)
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.
Secondary outcomes (11)
Glucose levels
Measured: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
PYY secretion
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Glucagon secretion
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
GIP secretion
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Insulin secretion
Measured: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
C-peptide secretion
Measured: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
CCK secretion
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Total ghrelin
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids fractions / FGF-19 concentrations
Measured: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)
Measured: -10, 30, 60, 120, 180 and 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Maria Saur Svane, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952963
- Sponsor's protocol ID
- IJ-GALDE3-16
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2016
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT02952963
- Acronym / sponsor ID
- IJ-GALDE3-16
- Conditions
- Severe Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 2 Nov 2016 (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 purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chenodeoxycholic Acid | Experimental | Drug: Chenodeoxycholic AcidChenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water. |
| Chenodeoxycholic Acid and Colesevelam | Experimental | Drug: Chenodeoxycholic Acid, Drug: ColesevelamChenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Uncomplicated RYGB performed minimum 3 months prior to the study.
- Fasting glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB
Key exclusion criteria (5 listed)
- Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB
- Dysregulated thyroid diseases, use of antithyroid treatment.
- Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
- Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake)
- Cholecystectomy.
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 |
|---|---|---|
| Chenodeoxycholic Acid | Drug | Chenodeoxycholic Acid, Chenodeoxycholic Acid and Colesevelam |
| Colesevelam | Drug | Chenodeoxycholic Acid and Colesevelam |
Primary outcome
GLP-1 secretion (evaluated by iAUC)
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.
11 secondary outcomes
Glucose levels
Time frame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
PYY secretion
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Glucagon secretion
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
GIP secretion
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Insulin secretion
Time frame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
C-peptide secretion
Time frame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
CCK secretion
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Total ghrelin
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids fractions / FGF-19 concentrations
Time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)
Time frame: -10, 30, 60, 120, 180 and 240 minutes
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 30 Nov 2020.
- Individual participant dataSharing planned: Yes
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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?
A Phase 4 study testing Chenodeoxycholic Acid and Colesevelam in people with Severe 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 2 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: finished, as of the sponsor's last update on 30 Nov 2020. 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 secretion (evaluated by iAUC) (time frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.). 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 30 Nov 2020.