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Completed

NCT Number: NCT01958775

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

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)

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 1L7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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.
  • Abnormal liver or thyroid function tests 6. Current addiction to alcohol or substances of abuse as determined by the investigator.
  • 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.

Treatment and study plan

GLP-2

Drug

single subcutaneous dose of 1500mcg

Other names: glucagon like peptide 2

Placebo

Drug

Primary outcomes

  1. Lipoprotein production and clearance rate

    Time frame: 10 hours

    ApoB 100 and ApoB 48 production and clearance

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 9, 2013
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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