NCT02656095

Completed

Lipoprotein Lipase Enzyme Activity Assay Validation and Clin...

University of Colorado, Denver Source

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Other study identifiers

Sponsor study identifier

15-1412

Secondary identifiers

UL1TR001082

NIH

Study Type

observational

Actual enrollment (reported)

12

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2016

Actual (reported)

Primary Completion

March 1, 2018

Actual (reported)

Study Completion

March 1, 2018

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 12 participants
Study completion date: March 1, 2018
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 12, 2016
Actual (reported)
First Posted
January 14, 2016
Actual (reported)
Study Start
March 2016
Actual (reported)
Primary Completion
March 1, 2018
Actual (reported)
Study Completion
March 1, 2018
Actual (reported)

Last Updated: July 11, 2019
Status Verified: July 2019
Last Update Submitted: July 9, 2019

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

HeparinDrug

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 39 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-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:

Sponsors & Collaborators

University of Colorado, Denver
Otherlead

MeSH Terms

Conditions

Hyperlipoproteinemia Type I

Interventions

Heparin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Study Officials

Robert Eckel, MD
University of Colorado, Denver
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

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 2016

Actual (reported)

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Unknown

NCT01448577

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Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous ECMO With a Heparin Bonded Circuit.

Not ApplicableWithdrawn

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Phase 1/2Unknown

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Phase 2Suspended

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)
+6 more criteria

Contact the study team to confirm eligibility.

GlycosaminoglycansPolysaccharidesCarbohydrates

Primary Completion

March 1, 2018

Actual (reported)

Study Completion

March 1, 2018

Actual (reported)

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02656095
Data provider: ClinicalTrials.gov
Source updated: 2019-07-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:32 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record