HyperlipidemiasPhase 2/3TED+GLC plasmaNCT03860688
Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins
A Phase 2/3 study testing TED + glucose in people with Hyperlipidemias, run by University Health Network, Toronto at 1 site 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) and glucose release the triglyceride from the gut is not known. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- TED + glucose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2019to May 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, aged 18 to 60 years.
- Body mass index 20 to 27 kg/m2
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 13Show 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
- Patients with hypersensitive to Revestive or any ingredient, active or a history of the drug within the last 5 years
- Patients with GI malignancy (GI tract, hepatobiliary, pancreatic)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Tornto General Hospital, UHN
Toronto, Ontario, M5G 1L7
Brenda Hughes, RN, 416-340-8886, brenda.hughes@uhn.ca
Gary F Lewis, MD
About this study
Official title: Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Injection of Analogue Glucagon-like Peptide-2 and Oral Glucose 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) and glucose release 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) ang glucose, given together, release stored triglyceride from the gut by evaluating how blood lipoproteins respond to teduglutide in healthy individuals.
Read the detailed description
The lipoprotein response will be performed in 15 healthy individuals recruited by newspaper advertisements. A member of the study team will explain the study in detail on visit 1, and if the individual is interested in participating, informed consent will be obtained and preliminary screening will occur. On visit 2 participants will receive a high fat liquid meal after an overnight fast. Hourly blood samples will be taken for 5 hours, followed by a subcutaneous teduglutide injection and simultaneous glucose drink. Following the injection and drink, blood samples will be taken every 15 minutes for the first hour and every 30 minutes for the subsequent 3 hours.
- Conditions
- Hyperlipidemias
- Being tested
- TED + glucose
- Keywords
- Intestinal lipoprotein, Gut peptide, Chylomicrons, Glucose
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TED + glucoseDrug
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide + glucose | Experimental | Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose Receives: Drug: TED + glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoprotein response to teduglutide and glucose
To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 May 2019
- Primary completion1 Dec 2021 (estimated)
- Study completionMay 2022 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- On visit 2, participants will receive teduglutide and glucose 5 hours after a liquid meal
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860688
- Sponsor's protocol ID
- TED+GLC plasma 18-6296
- Acronym
- TED+GLC plasma
- Status last verified
- Apr 2021
- First submitted
- 28 Feb 2019
- Last updated
- 29 Apr 2021
- 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 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Injection of Analogue Glucagon-like Peptide-2 and Oral Glucose in Humans
- ClinicalTrials.gov ID
- NCT03860688
- Acronym / sponsor ID
- TED+GLC plasma / TED+GLC plasma 18-6296
- Conditions
- Hyperlipidemias
- Keywords
- Intestinal lipoprotein, Gut peptide, Chylomicrons, Glucose
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 4 Mar 2019 (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) and glucose release 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) ang glucose, given together, release stored triglyceride from the gut by evaluating how blood lipoproteins respond to teduglutide in healthy individuals.
Detailed description
The lipoprotein response will be performed in 15 healthy individuals recruited by newspaper advertisements. A member of the study team will explain the study in detail on visit 1, and if the individual is interested in participating, informed consent will be obtained and preliminary screening will occur. On visit 2 participants will receive a high fat liquid meal after an overnight fast. Hourly blood samples will be taken for 5 hours, followed by a subcutaneous teduglutide injection and simultaneous glucose drink. Following the injection and drink, blood samples will be taken every 15 minutes for the first hour and every 30 minutes for the subsequent 3 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- On visit 2, participants will receive teduglutide and glucose 5 hours after a liquid meal
| Arm | Type | Receives |
|---|---|---|
| Teduglutide + glucose | Experimental | Drug: TED + glucoseTeduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women, aged 18 to 60 years.
- Body mass index 20 to 27 kg/m2
Key exclusion criteria (13 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 |
|---|---|---|
| TED + glucoseTeduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose | Drug | Teduglutide + glucose |
Primary outcome
Lipoprotein response to teduglutide and glucose
Time frame: 8 hours
To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- 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.
1 site 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 TED + glucose in people with Hyperlipidemias, run by University Health Network, Toronto at 1 site 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brenda Hughes, RN (416-340-4800 ext. 8886, brenda.hughes@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipoprotein response to teduglutide and glucose (time frame: 8 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 29 Apr 2021.