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Trial · Interventional

CompletedPhase 2/3Registry data

Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids

Short name GLP-2 Biopsy

NCTNCT03442972 (opens ClinicalTrials.gov in a new tab)Other id16-6368.2
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
21 participants (actual)
Sponsor
University Health Network, Toronto · Other
Design
Randomized · Single masking
Countries
1 country

Canada

Start
17 Jan 2019
Primary completion
1 Jun 2021
Completion
1 Dec 2021
First posted
22 Feb 2018
Last update posted
25 May 2022
Conditions
Hyperlipidemias

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 2/3

    GLP-2 Biopsy

    NCT03442972

    17 Jan 2019 to 1 Dec 2021

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) 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.

Interventions

  • TeduglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Teduglutide

    Teduglutide, up to 0.05mg/kg, subcutaneous, single dose

  • Placebo comparator

    Placebo

    Placebo, subcutaneous, single dose

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Release of enteral lipids in response to teduglutide

    Time frame · 6 hours

    Registry description

    To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment

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.

Completed trials do not always post results.

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
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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