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New treatment option for Lipoprotein Lipase Deficiency
Official title Postprandial Fatty Acid Metabolism in Subjects With Lipoprotein Lipase Deficiency
ClinicalTrials.gov ID: NCT04227678
What this study is testing
What is Heparin?
Heparin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lipoprotein lipase deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Lipoprotein lipase (LPL) is an enzyme that plays an important role in removing triglycerides (TG) (molecules that transport dietary fat) from the blood. Patients with LPL deficiency (LPLD) display during their whole life very high plasma TG levels often associated with episodes of postprandial abdominal pain, malaise, blurred vision, dizziness (hyperchylomicronemia syndrome) that may lead to recurrent pancreatitis episodes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 8 healthy LPL-deficient individuals (LPLD people) with history of fasting TG \> 5 mmol/l and homozygote or compound heterozygote for a LPL-gene...
- 8 control people (fasting glucose \< 5.6, 2-hour post 75g OGTT glucose \< 7.8 mmol/l and HbA1c \< 5.8%; fasting TG \< 1.5 mmol/l);
- age 18 to 75 yo;
- To be willing and able to adhere to the specifications of the protocol;
- To have signed an informed consent document indicating that they understood the purpose
You likely can't join if
- age \< 18 yo;
- overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
- Treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin...
- Treatment with anti-hypertensive medication (only for LPL-deficient individuals);
- presence of liver or renal disease; uncontrolled thyroid disorder;
- previous diagnosis of heparin-induced thrombocytopenia;
See the full eligibility criteria
- 8 healthy LPL-deficient individuals (LPLD people) with history of fasting TG \> 5 mmol/l and homozygote or compound heterozygote for a LPL-gene mutation;
- 8 control people (fasting glucose \< 5.6, 2-hour post 75g OGTT glucose \< 7.8 mmol/l and HbA1c \< 5.8%; fasting TG \< 1.5 mmol/l);
- age 18 to 75 yo;
- To be willing and able to adhere to the specifications of the protocol;
- To have signed an informed consent document indicating that they understood the purpose
- age \< 18 yo;
- overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
- Treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted);
- Treatment with anti-hypertensive medication (only for LPL-deficient individuals);
- presence of liver or renal disease; uncontrolled thyroid disorder;
- previous diagnosis of heparin-induced thrombocytopenia;
- Treatment with oral anticoagulation medication or platelet aggregation inhibiting drugs;
- A history of major hemorrhagic event;
- smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day;;
- Female of child-bearing potential who is pregnant, breast feeding or intends to become pregnant or pre-menopausal female with a positive serum pregnancy test at the time of enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.