Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

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
    



Study Type

Observational


Primary Outcome

Evaluation of Lipoprotein lipase levels


Condition

Lipoprotein Lipase Deficiency

Intervention

Heparin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

March 2016

Completion Date

March 1, 2018

Primary Completion Date

March 1, 2018

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)
      

Gender

All

Ages

20 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Robert Eckel, MD, , 



Administrative Informations


NCT ID

NCT02656095

Organization ID

15-1412

Secondary IDs

UL1TR001082

Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver


Study Sponsor

Robert Eckel, MD, Principal Investigator, University of Colorado, Denver


Verification Date

July 2019