Severe ObesityPhase 4NCT02876484

Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

A Phase 4 study testing Colesevelam, Chenodeoxycholic Acid and Water in people with Severe Obesity, run by Hvidovre University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to examine the effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, 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?: Colesevelam, Chenodeoxycholic Acid and Water
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteDenmark
Study dates: Jun 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 plasma 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.

Denmark1 site

Hvidovre University Hospital
Hvidovre, DK-2650

Other trials in Denmark

About this study

Official title: Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass

The purpose of this study is to examine the effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.

Conditions: Severe Obesity
Being tested: Colesevelam, Chenodeoxycholic Acid, Water
Medical subject headings: Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ColesevelamDrug
Chenodeoxycholic AcidDrug
WaterOther

Study groups in NCT02876484
Study group	Role	What they receive
Placebo	Experimental	Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water Receives: Other: Water
Chenodeoxycholic Acid	Experimental	Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt Receives: Drug: Chenodeoxycholic Acid
Colesevelam	Experimental	Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt. Receives: Drug: Colesevelam
Colesevelam x 2	Experimental	plus (on another study day) 3,75 g colesevelam administered the evening before the experiment. Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt. Receives: 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, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal

Secondary outcomes (12)

Glucose levels
Measured: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Insulin secretion
Measured: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PYY secretion
Measured: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids/FGF19 concentrations
Measured: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)
Measured: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PCM levels
Measured: Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
C-peptide secretion
Measured: Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Glucagon secretion
Measured: Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
GIP secretion
Measured: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
CCK secretion
Measured: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Ghrelin
Measured: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion
Measured: 0, 10, 20, 30, 45, 60, 90, 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.

Jun 2016Nov 2020

First posted23 Aug 2016 (estimated)
Study startJun 2016
Primary completionJun 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02876484
Sponsor's protocol ID: IJ-G2-16
Status last verified: Nov 2020
First submitted: 1 Jul 2016
Last updated: 30 Nov 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Severe Obesity trials

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: Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass
ClinicalTrials.gov ID: NCT02876484
Acronym / sponsor ID: IJ-G2-16
Conditions: Severe Obesity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Hvidovre University HospitalUniversity, hospital or other
Collaborators: University of Copenhagen
Study start: Jun 2016
Primary completion: Jun 2017 (actual)
Study completion: Nov 2020 (actual)
First posted: 23 Aug 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 effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, 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: 4

Arm	Type	Receives
Placebo	Experimental	Other: WaterMorning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water
Chenodeoxycholic Acid	Experimental	Drug: Chenodeoxycholic AcidMorning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt
Colesevelam	Experimental	Drug: ColesevelamMorning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.
Colesevelam x 2	Experimental	Drug: Colesevelamplus (on another study day) 3,75 g colesevelam administered the evening before the experiment. Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

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 plasma 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
Colesevelam	Drug	Colesevelam, Colesevelam x 2
Chenodeoxycholic Acid	Drug	Chenodeoxycholic Acid
Water	Other	Placebo

Primary outcome

GLP-1 secretion (evaluated by iAUC)
Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal

12 secondary outcomes

Glucose levels
Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Insulin secretion
Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PYY secretion
Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids/FGF19 concentrations
Time frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)
Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PCM levels
Time frame: Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
C-peptide secretion
Time frame: Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Glucagon secretion
Time frame: Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
GIP secretion
Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
CCK secretion
Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Ghrelin
Time frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion
Time frame: 0, 10, 20, 30, 45, 60, 90, 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

Related trials for Severe Obesity

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
RecruitingPhase 3
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Crohn's Disease, Obesity or Overweight
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Ulcerative Colitis, Obesity or Overweight
Active, not recruitingPhase 3
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Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

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 Colesevelam, Chenodeoxycholic Acid and Water 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, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal). 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 NCT02876484.

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.