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Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids (GLP-2 Biopsy)

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ClinicalTrials.gov Identifier: NCT03442972
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Kensington Screening Clinic
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Drug: Teduglutide Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: Single-blinded study with participant blinded to treatment
Primary Purpose: Basic Science
Official Title: Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Teduglutide
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose
Drug: Teduglutide
Teduglutide

Placebo Comparator: Placebo
Placebo, subcutaneous, single dose
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442972


Contacts
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Contact: Brenda Hughes, RN 416-340-4800 ext 8886 brenda.hughes@uhn.ca

Locations
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Canada, Ontario
Toronto General Hopital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Brenda Hughes, RN    416-340-8886    brenda.hughes@uhn.ca   
Contact: Gary Lewis, MD FRCPC    416-340-4270    gary.lewis@uhn.ca   
Principal Investigator: Gary Lewis, MD FRCPC         
Kensington Screening Clinic Not yet recruiting
Toronto, Ontario, Canada, M5T 3A9
Contact: Ian Bookman, MD         
Sponsors and Collaborators
University Health Network, Toronto
Kensington Screening Clinic
Investigators
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Principal Investigator: Gary Lewis, MD UHN

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03442972     History of Changes
Other Study ID Numbers: GLP-2 Biopsy 16-6368
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University Health Network, Toronto:
Intestinal lipoprotein
Duodenal biopsy
Gut Peptide
Chylomicrons

Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Glucagon
Teduglutide
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins
Radiation-Protective Agents
Protective Agents