Lipoprotein Lipase DeficiencyNCT02656095
Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
An observational study of Lipoprotein Lipase Deficiency, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoprotein Lipase Deficiency
- What is being tested?
- Heparin
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Male and female individuals
Who may be able to join
- 1. male and females between ages of 20-39
Who cannot join
- 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
Show all 21Show fewer
- 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)
About this study
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.
Read more
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
- Being tested
- Heparin
- Medical subject headings
- Hyperlipoproteinemia Type I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Lipoprotein lipase levels
Blood will be drawn after IV heparin administration and run through assay to determine lipoprotein lipase levels.
Measured: 10-15 minutes post-heparin adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein Lipase DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Eckel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656095
- Sponsor's protocol ID
- 15-1412
- Other IDs
- UL1TR001082
- Status last verified
- Jul 2019
- First submitted
- 12 Jan 2016
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
- ClinicalTrials.gov ID
- NCT02656095
- Acronym / sponsor ID
- 15-1412
- Conditions
- Lipoprotein Lipase Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Male and female individuals
Key inclusion criteria (1 listed)
- 1. male and females between ages of 20-39
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinParticipants 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. | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Eckel, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Lipoprotein Lipase Deficiency, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Lipoprotein lipase levels (time frame: 10-15 minutes post-heparin adminstration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.