Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

NCT02656095 | Completed DMC

• 2 other identifiers: 15-1412UL1TR001082
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Conditions

Lipoprotein Lipase Deficiency

Outcome Measures

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.

  10-15 minutes post-heparin adminstration

Interventions

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.

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Male and female individuals

You may qualify if:

• \. male and females between ages of 20-39

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Hyperlipoproteinemia Type I

Interventions

Heparin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Robert Eckel, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share