Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

Short name TED+GLC plasma

NCTNCT03860688Other idTED+GLC plasma 18-6296

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 2/3
Enrollment: 15 participants (estimated)
Sponsor: University Health Network, Toronto · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Canada
Start: 1 May 2019
Primary completion: 1 Dec 2021 (estimated)
Completion: May 2022 (estimated)
First posted: 4 Mar 2019
Last update posted: 29 Apr 2021
Conditions: Hyperlipidemias

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020202120222023

Ph 2/3
TED+GLC plasma
NCT03860688
1 May 2019 to est. May 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TED + glucoseDrug

Arms1

Experimental
Teduglutide + glucose
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose

Primary outcomes1

Outcomes the sponsor listed as primary.

Lipoprotein response to teduglutide and glucose
Time frame · 8 hours
Registry description
To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Men and women, aged 18 to 60 years. * Body mass index 20 to 27 kg/m2 Exclusion Criteria: 1. Patients with active inflammatory bowel disease 2. Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption 3. Patients with active bowel malignancy 4. Patients with diabetes mellitus or known/ suspected motility disorders of the gut 5. Patients with decompensated liver disease 6. Patients on ezetimibe or bile acid sequestrants 7. Patients who are pregnant or breastfeeding. 8. Patients with renal disease. 9. Patients on benzodiazepine. 10. Unstable cardiac or respiratory disease 11. Any changes to medication in the preceding month 12. Patients with hypersensitive to Revestive or any ingredient, active or a history of the drug within the last 5 years 13. Patients with GI malignancy (GI tract, hepatobiliary, pancreatic)

PepBank is a research reference. Talk to a doctor before you use any peptide.