Effects of Oral Glucose and Teduglutide on Plasma Lipopro... | NCT03860688

Studies
Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

NCT03860688

Sponsor

University Health Network, Toronto

Status

Unknown status

Last Update Posted

Apr 29, 2021Actual

Enrollment

15Estimated

Phase

Phase 2Phase 3

Conditions

Hyperlipidemias

Interventions

TED + glucose

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

May 2022Estimated

First Submitted Date

Feb 28, 2019

First Submission Date that Met QC Criteria

Feb 28, 2019

First Posted Date

Mar 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2021

Last Update Posted Date

Apr 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teduglutide + glucose	Experimental	Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose	Drug: TED + glucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TED + glucose	Drug	Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose	Teduglutide + glucose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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
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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brenda Hughes, RN	Contact	416-340-4800	8886	brenda.hughes@uhn.ca
Gary Lewis, MD	Contact	416-340-4270		gary.lewis@uhn.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tornto General Hospital, UHN	Recruiting	Toronto	Ontario	M5G 1L7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided