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Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like Peptide 2

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

GLP-2

Placebo

About this trial

This is an interventional basic science trial for Dyslipidemia focused on measuring Lipoproteins, apoB, GLP-2

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion Criteria:
1. Men and women, aged 18 to 60 years
2. Body mass index 20 kg/m2 to 30 kg/m2
3. Hemoglobin above 130g/L.
4. Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test (OGTT)

Exclusion Criteria:

1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180) or proliferative retinopathy 3. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
4. Any history of ischemic heart disease or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
5. Abnormal liver or thyroid function tests 6. Current addiction to alcohol or substances of abuse as determined by the investigator.
7. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 8. Taking any prescription or non-prescription medications at the time of the study 9. Having donated blood three months prior to and three months post study procedures 10. A pregnancy test will be performed 1 to 3 days prior to each study in all female research participants. Those who test positive for pregnancy will be excluded.

Sites / Locations

Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLP=2

Placebo

Arm Description

active treatment with a single dose of GLP-2 (1500mcg)

placebo

Outcomes

Primary Outcome Measures

Lipoprotein production and clearance rate

ApoB 100 and ApoB 48 production and clearance

Secondary Outcome Measures

Plasma and TRL triglyceride and TRL retinyl palmitate

Measurements will be carried out hourly after ingestion of meal and then every 15-30 minutes thereafter to see if GLP-2 increases these parameters compared to placebo.

Full Information

NCT ID

NCT01958775

First Posted

October 7, 2013

Last Updated

March 6, 2015

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01958775

Brief Title

Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like Peptide 2

Official Title

Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study A) To assess whether GLP-2 affects the release of preformed chylomicrons (study B)

Detailed Description

Study A: Using constant feeding with a nasoduodenal tube and stable isotope infusion, mathematical modelling will be utilised to measure lipoprotein production and clearance. The lipoproteins assessed will be apoB-100 from the liver and apoB-48 from the intestine. StudyB: Volunteers will be given a liquid meal with retinyl palmitate (vitamin A) to label chylomicrons made from the meal. 7 hours later they will be given GLP-2 or placebo. Measurements of plasma and TRL(triglyceride rich lipoprotein) triglyceride and TRL retinyl palmitate will be carried out to see whether GLP-2 increases these parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

Lipoproteins, apoB, GLP-2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLP=2

Arm Type

Experimental

Arm Description

active treatment with a single dose of GLP-2 (1500mcg)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

GLP-2

Other Intervention Name(s)

glucagon like peptide 2

Intervention Description

single subcutaneous dose of 1500mcg

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Lipoprotein production and clearance rate

Description

ApoB 100 and ApoB 48 production and clearance

Time Frame

10 hours

Secondary Outcome Measure Information:

Title

Plasma and TRL triglyceride and TRL retinyl palmitate

Description

Measurements will be carried out hourly after ingestion of meal and then every 15-30 minutes thereafter to see if GLP-2 increases these parameters compared to placebo.

Time Frame

10 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria: Men and women, aged 18 to 60 years Body mass index 20 kg/m2 to 30 kg/m2 Hemoglobin above 130g/L. Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test (OGTT) Exclusion Criteria: 1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years. 2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180) or proliferative retinopathy 3. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance. 4. Any history of ischemic heart disease or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure. 5. Abnormal liver or thyroid function tests 6. Current addiction to alcohol or substances of abuse as determined by the investigator. 7. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 8. Taking any prescription or non-prescription medications at the time of the study 9. Having donated blood three months prior to and three months post study procedures 10. A pregnancy test will be performed 1 to 3 days prior to each study in all female research participants. Those who test positive for pregnancy will be excluded.

Facility Information:

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1L7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25173752

Citation

Dash S, Xiao C, Morgantini C, Connelly PW, Patterson BW, Lewis GF. Glucagon-like peptide-2 regulates release of chylomicrons from the intestine. Gastroenterology. 2014 Dec;147(6):1275-1284.e4. doi: 10.1053/j.gastro.2014.08.037. Epub 2014 Aug 28.

Results Reference

derived

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Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like Peptide 2

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