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Trial · Interventional

CompletedNot applicableRegistry data

Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans

NCTNCT01056549 (opens ClinicalTrials.gov in a new tab)Other idREB 09-0428-B
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
15 participants (actual)
Sponsor
University Health Network, Toronto · Other
Design
Randomized · Single masking
Countries
1 country

Canada

Start
Jan 2010
Primary completion
Sept 2011
Completion
Sept 2011
First posted
26 Jan 2010 (estimated)
Last update posted
22 Jun 2012 (estimated)
Conditions
Hyperlipidemia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. N/A

    Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans

    NCT01056549

    Jan 2010 to Sept 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Exenatide acutely inhibits intestinal lipoprotein particle production. We are unable to speculate whether exenatide affects hepatic lipoprotein production in humans since there is currently no evidence from animal models or in vitro studies that have demonstrated an effect

Interventions

  • exenatideDrug

Arms1

  • Experimental

    exenatide subcutaneous injection

    Study A: lipoprotein turnover following subcutaneous exenatide administration, under conditions of pancreatic clamp. Study B: lipoprotein turnover study following subcutaneous placebo administration, under conditions of pancreatic clamp.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The objective is to examine the change in apoB48 production rate after one subcutaneous injection of exenatide, under conditions of a pancreatic clamp and a steady state fed state.

    Time frame · over 10 hours

Secondary outcomes(1)

  1. The secondary objective is to examine the change in apoB100 production rate in the same conditions, and the secondary measure is the difference between exenatide and placebo in the mean production of TRL-apoB100

    Time frame · over 10 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

4 results

Exenatide, a glucagon-like peptide-1 receptor agonist, acutely inhibits intestinal lipoprotein production in healthy humans.

Xiao et al. 2012Arteriosclerosis, thrombosis, and vascular biologycited by 129

PMID 22492091DOI 10.1161/atvbaha.112.246207PUB-22492091

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Men and women, aged 18 to 60 years 2. Body mass index 20 kg/m2 to 25 kg/m2 3. Hemoglobin above 130g/L. 4. Normal glucose tolerance in response to a 75g, 2-hr 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 a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure. 5. Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH \> 6 mU/l 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 subjects. Those who test positive for pregnancy will be excluded. 11. No clinical evidence of neoplasms which have been known to overexpress GLP-1 receptors i.e. pheochromocytomas, brain tumors and embryonic tumors. 12. Hypersensitivity to egg-, soya-,or peanut protein or previous allergy to intralipid 13. Those with known sensitivity to metoclopramide

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