Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

NCT03860688 | Unknown Phase 2

• 1 other identifier: TED+GLC plasma 18-6296
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Hyperlipidemias

Keywords

Intestinal lipoprotein; Gut peptide; Chylomicrons; Glucose

Outcome Measures

Primary Outcomes (1)

• Lipoprotein response to teduglutide and glucose

  To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals

  8 hours

Study Arms (1)

Teduglutide + glucose

EXPERIMENTAL

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

Drug: TED + glucose

Interventions

TED + glucose DRUG

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

Teduglutide + glucose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, aged 18 to 60 years.
• Body mass index 20 to 27 kg/m2

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Tornto General Hospital, UHN

Toronto, Ontario, M5G 1L7, Canada

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Glucose

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Brenda Hughes, RN

CONTACT

416-340-4800; brenda.hughes@uhn.ca

Gary Lewis, MD

CONTACT

416-340-4270; gary.lewis@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: On visit 2, participants will receive teduglutide and glucose 5 hours after a liquid meal

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)