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Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

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ClinicalTrials.gov Identifier: NCT02656095
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans. LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no longer functional. This can cause conditions known as high triglycerides in the blood and inflammation of the pancreas.

Investigational medications to treat LPLD are currently being developed. In order to see if these medications are effective, it is necessary to be able to accurately measure LPL activity in humans.

LPL activity has been successfully measured in animal models after giving heparin. Heparin is a blood thinner which is approved by the FDA. It is originally used to prevent blood clots. This study will administer heparin to healthy adults through intravenous infusion (IV). Blood samples will be collected before and after the infusion to test LDL levels.

The purpose of this study is to develop a cheap, more reliable standard for assessment of LPLD in patients


Condition or disease Intervention/treatment
Lipoprotein Lipase Deficiency Drug: Heparin

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
Actual Study Start Date : March 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018



Intervention Details:
  • Drug: Heparin
    Participants will be given IV heparin in order to release lipoprotein lipase from capillary endothelial cells. Blood will be drawn 10-15 minutes post-heparin administration and run through assay to determine lipoprotein lipase levels.


Primary Outcome Measures :
  1. Evaluation of Lipoprotein lipase levels [ Time Frame: 10-15 minutes post-heparin adminstration ]
    Blood will be drawn after IV heparin administration and run through assay to determine lipoprotein lipase levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Male and female individuals
Criteria

Inclusion Criteria:

1. male and females between ages of 20-39

Exclusion Criteria:

  1. Past history of LPL deficiency
  2. Hypercholesterolemia (Cholesterol >200, LDL >160, HDL <35) hypertriglyceridemia (TG>150), any familial lipid disorder
  3. Diabetes mellitus (type 1 or 2)
  4. Uncontrolled hypertension SBP>140, DBP>90
  5. History of hemorrhagic stroke
  6. Current pregnancy
  7. History of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study
  8. Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening
  9. History of allergy to heparin
  10. History of heparin-induced thrombocytopenia
  11. Current smoking
  12. Active ulcerative or angiodysplastic GI diseases
  13. Thrombocytopenia or platelet disorders (Platelet count <100,000/UL)
  14. Major health issues which may affect the safety of study subject, including but not limited to:

    • History of chronic kidney disease (eGFR<60)
    • Long term use of medications which alter lipid metabolism
    • History of hepatic disease (ALT or AST more than 2 times the upper limit of normal)
    • History of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia
    • Chronic use of ASA, anticoagulants, platelet inhibitors
    • Use of NSAIDS for more than 2 weeks prior to screening
    • Anemia (hemoglobin <13 g/dL)

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): NCT02656095


Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Robert Eckel, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02656095     History of Changes
Other Study ID Numbers: 15-1412
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type I
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action