HyperlipidemiasPhase 2/3GLP-2 BiopsyNCT03442972
Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids
A Phase 2/3 study testing Teduglutide in people with Hyperlipidemias, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Teduglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- 17 Jan 2019to 1 Dec 2021
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman of the Kensington Screening Clinic, Toronto, ON, Canada
Who cannot join
- Patients with active inflammatory bowel disease
- Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
- Patients with active bowel malignancy
- Patients with diabetes mellitus or known/ suspected motility disorders of the gut
- Patients with decompensated liver disease
- Patients on ezetimibe or bile acid sequestrants
Show all 11Show fewer
- Patients who are pregnant or breastfeeding.
- Patients with renal disease
- Patients on benzodiazepine
- Unstable cardiac or respiratory disease
- Any changes to medication in the preceding month
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto General Hopital
Toronto, Ontario, M5G 2C4
Kensington Screening Clinic
Toronto, Ontario, M5T 3A9
About this study
Official title: Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans
Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known. The research team in this study is interested in finding out how teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut by studying samples from patients undergoing endoscopy and small bowel biopsy.
Read the detailed description
The release of stored enteral lipids will be investigated in 30 patients undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications. Patients undergoing the procedure will be recruited. Participants will have a high fat liquid meal as breakfast. 5 hours later, participants will be randomly assigned to receive either a subcutaneous injection of placebo (n=15) or a subcutaneous injection of the Health Canada approved glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15 different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3 sample sites,snap frozen in dry ice and stored at -80°C for further analysis.
- Conditions
- Hyperlipidemias
- Being tested
- Teduglutide, Placebo
- Keywords
- Intestinal lipoprotein, Duodenal biopsy, Gut Peptide, Chylomicrons
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
Teduglutide
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide | Experimental | Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Receives: Drug: Teduglutide |
| Placebo | Placebo comparator | Placebo, subcutaneous, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Release of enteral lipids in response to teduglutide
To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start17 Jan 2019
- Primary completion1 Jun 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to receive either teduglutide or placebo as a single subcutaneous injection, 1 hour prior to duodenal biopsy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kensington Screening Clinic
- Responsible party
- Sponsor
- Investigators
- Gary F Lewis, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442972
- Sponsor's protocol ID
- 16-6368.2
- Acronym
- GLP-2 Biopsy
- Status last verified
- Nov 2020
- First submitted
- 2 Feb 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans
- ClinicalTrials.gov ID
- NCT03442972
- Acronym / sponsor ID
- GLP-2 Biopsy / 16-6368.2
- Conditions
- Hyperlipidemias
- Keywords
- Intestinal lipoprotein, Duodenal biopsy, Gut Peptide, Chylomicrons
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Kensington Screening Clinic
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 22 Feb 2018 (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.
Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known. The research team in this study is interested in finding out how teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut by studying samples from patients undergoing endoscopy and small bowel biopsy.
Detailed description
The release of stored enteral lipids will be investigated in 30 patients undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications. Patients undergoing the procedure will be recruited. Participants will have a high fat liquid meal as breakfast. 5 hours later, participants will be randomly assigned to receive either a subcutaneous injection of placebo (n=15) or a subcutaneous injection of the Health Canada approved glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15 different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3 sample sites,snap frozen in dry ice and stored at -80°C for further analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive either teduglutide or placebo as a single subcutaneous injection, 1 hour prior to duodenal biopsy
| Arm | Type | Receives |
|---|---|---|
| Teduglutide | Experimental | Drug: TeduglutideTeduglutide, up to 0.05mg/kg, subcutaneous, single dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, subcutaneous, single dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman of the Kensington Screening Clinic, Toronto, ON, Canada
Key exclusion criteria (11 listed)
- Patients with active inflammatory bowel disease
- Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
- Patients with active bowel malignancy
- Patients with diabetes mellitus or known/ suspected motility disorders of the gut
- Patients with decompensated liver disease
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 |
|---|---|---|
| TeduglutideTeduglutide | Drug | Teduglutide |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Release of enteral lipids in response to teduglutide
Time frame: 6 hours
To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment
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 25 May 2022.
- Individual participant dataSharing planned: No
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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.
Gary F Lewis, MD principal investigator
UHN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Teduglutide in people with Hyperlipidemias, run by University Health Network, Toronto at 2 sites in Canada.
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 1 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Release of enteral lipids in response to teduglutide (time frame: 6 hours). 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 25 May 2022.