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Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

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: 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

Tracking Information
First Submitted Date January 12, 2016
First Posted Date January 14, 2016
Last Update Posted Date July 11, 2019
Actual Study Start Date March 2016
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2017)
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.
Original Primary Outcome Measures
 (submitted: January 13, 2016)
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.
Change History Complete list of historical versions of study NCT02656095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
Official Title Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy Male and female individuals
Condition Lipoprotein Lipase Deficiency
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 13, 2016)
12
Original Estimated Enrollment Same as current
Actual Study Completion Date March 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 39 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02656095
Other Study ID Numbers 15-1412
UL1TR001082 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Robert Eckel, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date July 2019