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Trial record 38 of 809 for:    APOB

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01958775
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: GLP-2 Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like
Study Start Date : March 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: GLP=2
active treatment with a single dose of GLP-2 (1500mcg)
Drug: GLP-2
single subcutaneous dose of 1500mcg
Other Name: glucagon like peptide 2

Placebo Comparator: Placebo
placebo
Drug: Placebo



Primary Outcome Measures :
  1. Lipoprotein production and clearance rate [ Time Frame: 10 hours ]
    ApoB 100 and ApoB 48 production and clearance


Secondary Outcome Measures :
  1. Plasma and TRL triglyceride and TRL retinyl palmitate [ Time Frame: 10 hours ]
    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.



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:   Yes
Criteria

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.


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): NCT01958775


Locations
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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 1L7
Sponsors and Collaborators
University Health Network, Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01958775     History of Changes
Other Study ID Numbers: REB-07-0394
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by University Health Network, Toronto:
Lipoproteins, apoB, GLP-2
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins