Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

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

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Key information

Conditions

Lipoprotein Lipase Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type I Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

male and females between ages of 20-39

Exclusion criteria

Past history of LPL deficiency
Hypercholesterolemia (Cholesterol >200, LDL >160, HDL <35) hypertriglyceridemia (TG>150), any familial lipid disorder
Diabetes mellitus (type 1 or 2)
Uncontrolled hypertension SBP>140, DBP>90
History of hemorrhagic stroke
Current pregnancy
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
Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening
History of allergy to heparin
History of heparin-induced thrombocytopenia
Current smoking
Active ulcerative or angiodysplastic GI diseases
Thrombocytopenia or platelet disorders (Platelet count <100,000/UL)
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)

Treatment and study plan

Heparin

Drug

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jan 14, 2016
Registry last updated: Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed