Severe ObesityPhase 4NCT02340247
Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass
A Phase 4 study testing Water, Ursodeoxycholic Acid and Chenodeoxycholic Acid 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 effects of bile acids on GLP-1 secretion 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?
- Water, Ursodeoxycholic Acid and Chenodeoxycholic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Apr 2015
- 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 < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB.
Who cannot join
- Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB.
- Dysregulated hypothyroidism, 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass
The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.
- Conditions
- Severe Obesity
- Being tested
- Water, Ursodeoxycholic Acid, Chenodeoxycholic Acid
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Ursodeoxycholic AcidDrug
Chenodeoxycholic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | 150mL water Receives: Other: Water |
| Ursodeoxycholic acid | Experimental | Ursodeoxycholic acid (750mg) dissolved in 150mL water Receives: Drug: Ursodeoxycholic Acid |
| Chenodeoxycholic acid | Experimental | Chenodeoxycholic acid (1250mg) dissolved in 150mL water Receives: Drug: Chenodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 secretion (evaluated by iAUC)
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Secondary outcomes (9)
C-peptide secretion (evaluated by iAUC)
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
PYY secretion (evaluated by iAUC)
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Glucagon secretion (evaluated by iAUC)
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
GIP secretion (evaluated by iAUC)
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
CCK secretion (evaluated by iAUC)
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Gherlin secretion (evaluated by iAUC)
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Changes in bile acids/FGF-19
Measured: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
TSH/T3/T4
Measured: 0, 60, 120, 180
Appetite measurements (VAS-score)
Measured: Baseline, 30, 60, 120, 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2015
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT02340247
- Sponsor's protocol ID
- SN-GALDE-14
- Status last verified
- Jun 2016
- First submitted
- 13 Jan 2015
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT02340247
- Acronym / sponsor ID
- SN-GALDE-14
- Conditions
- Severe Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- First posted
- 16 Jan 2015 (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 acids on GLP-1 secretion after Roux-en-Y gastric bypass.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: Water150mL water |
| Ursodeoxycholic acid | Experimental | Drug: Ursodeoxycholic AcidUrsodeoxycholic acid (750mg) dissolved in 150mL water |
| Chenodeoxycholic acid | Experimental | Drug: Chenodeoxycholic AcidChenodeoxycholic acid (1250mg) dissolved in 150mL 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 plasma glucose < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB.
Key exclusion criteria (4 listed)
- Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB.
- Dysregulated hypothyroidism, 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).
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 |
|---|---|---|
| Water | Other | Placebo |
| Ursodeoxycholic Acid | Drug | Ursodeoxycholic acid |
| Chenodeoxycholic Acid | Drug | Chenodeoxycholic acid |
Primary outcome
GLP-1 secretion (evaluated by iAUC)
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
9 secondary outcomes
C-peptide secretion (evaluated by iAUC)
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
PYY secretion (evaluated by iAUC)
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Glucagon secretion (evaluated by iAUC)
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
GIP secretion (evaluated by iAUC)
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
CCK secretion (evaluated by iAUC)
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Gherlin secretion (evaluated by iAUC)
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Changes in bile acids/FGF-19
Time frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
TSH/T3/T4
Time frame: 0, 60, 120, 180
Appetite measurements (VAS-score)
Time frame: Baseline, 30, 60, 120, 180
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 Jun 2016.
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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 Water, Ursodeoxycholic Acid and Chenodeoxycholic Acid 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 4 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 Jun 2016. 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: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180). 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 Jun 2016.