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CompletedNCT02656095Updated Jul 11, 2019

Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

An observational study in Lipoprotein Lipase Deficiency, sponsored by University of Colorado, Denver. Completed. Open to participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-11.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
20 Years to 39 Years
Sex
All
01

Study 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

02

Conditions studied

  • Lipoprotein Lipase Deficiency
03

In context

Hyperlipoproteinemia Type I

23 studies on the registry are indexed under Hyperlipoproteinemia Type I; 3 are open to participants now.

Browse Hyperlipoproteinemia Type I studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Male and female individuals

Inclusion criteria

  1. male and females between ages of 20-39

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • DrugHeparin

    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.

06

What researchers measure

Primary outcomes

  1. Evaluation of Lipoprotein lipase levels

    Blood will be drawn after IV heparin administration and run through assay to determine lipoprotein lipase levels.

    Time frame: 10-15 minutes post-heparin adminstration

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02656095
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jan 14, 2016
Start date
Mar 2016
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Last update
Jul 11, 2019

Study contacts

Robert Eckel, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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