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RecruitingNCT04227678AGL12Updated Feb 10, 2026

Postprandial Fatty Acid Metabolism in Subjects With Lipoprotein Lipase Deficiency

An interventional study of Heparin and liquid meal in Lipoprotein Lipase Deficiency, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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. Because of their very slow clearance in blood of their chylomicron-TG, these patients need to severely restrict their dietary fat intake to avoid these complications. Fortunately, novel treatments are being developed to circumvent LPL deficiency (LPLD) metabolic effect on chylomicron-TG clearance. However, there is no data on how LPLD affect organ-specific dietary fatty acid metabolism nor how the novel therapeutic agents may change this metabolism. For example, it is currently not understood how subjects with LPLD store their DFA into adipose tissues and whether they are able to use DFA as a fuel to sustain their cardiac metabolism, as healthy individuals do. This study aims to better understand theses two questions.

Read the detailed description

The study protocol includes 3 visits: the screening visit and 2 postprandial metabolic studies performed in random order at an interval of 7 to 14 days, and performed with (A1) and without (A0) an intravenous (i.v.) heparin bolus followed by 250 IU/h i.v during 6 hours. Each metabolic study will last 9 hours (with 6 hours postprandial) and will include PET and stable isotopic tracer methods. At time 0, a low fat liquid meal will be ingested over 20 minutes.

02

Conditions studied

  • Lipoprotein Lipase Deficiency
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 8 healthy LPL-deficient individuals (LPLD subjects) with history of fasting TG > 5 mmol/l and homozygote or compound heterozygote for a LPL-gene mutation;
  • 8 control subjects (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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Other
    Control group- A0

    Control group: Healthy subjects with fasting glucose \< 5.6, 2-hour post 75g Oral Glucose Tolerance Test (OGTT) glucose \< 7.8 mmol/l and HbA1c \< 5.8%; fasting TG \< 1.5 mmol/l); A0: without heparin administered

    Dietary Supplement: liquid meal

  • Other
    LPLD group-A0

    LPLD group: LPL deficient subjects with history of fasting TG \> 5 mmol/l and homozygote or compound heterozygote for a LPL-gene mutation; A0: without heparin administered

    Dietary Supplement: liquid meal

  • Other
    Control group-A1

    Control group: Healthy subjects with fasting glucose \< 5.6, 2-hour post 75g OGTT glucose \< 7.8 mmol/l and HbA1c \< 5.8%; fasting TG \< 1.5 mmol/l); A1: with an intravenous (i.v.) heparin bolus (50 IU/kg i.v.) followed by 250 IU/h i.v. during 6 hours starting 15 minutes before ingestion of liquid meal.

    Drug: Heparin · Dietary Supplement: liquid meal

  • Other
    LPLD group-A1

    LPLD group: LPL deficient subjects with history of fasting TG \> 5 mmol/l and homozygote or compound heterozygote for a LPL-gene mutation; A1: with an intravenous (i.v.) heparin bolus (50 IU/kg i.v.) followed by 250 IU/h i.v. during 6 hours starting 15 minutes before ingestion of liquid meal.

    Drug: Heparin · Dietary Supplement: liquid meal

Interventions

  • DrugHeparin

    an intravenous (i.v.) heparin bolus (50 IU/kg i.v.) followed by 250 IU/h i.v. during 6 hours, starting 15 minutes before ingestion of liquid meal

  • Dietary supplementliquid meal

    low fat meal: (500 mL, 898 Kcal, 13% fat, 20.3% protein and 62.3% carbohydrates) will be ingested over 20 minutes

05

What researchers measure

Primary outcomes

  1. Organ-specific Dietary Fatty Acid (DFA) partitioning

    will be determined using oral administration of \[18F \]-Fluoro-6-Thia- Heptadecanoic Acid (FTHA ) during whole-body acquisition.

    Time frame: 2 months

  2. Myocardial DFA uptake

    will be assessed using oral administration of \[18F\]-FTHA during dynamic PET acquisition.

    Time frame: 2 months

Secondary outcomes

  1. Myocardial nonesterified fatty acids (NEFA) metabolism

    will be determined using \[11C\]-palmitate during dynamic PET acquisition.

    Time frame: 2 months

  2. Dietary fatty acid oxidation rate

    will be measured using breath \[13C\]-carbon dioxide enrichment

    Time frame: 6 months

  3. Total oxidation rate

    will be determined by indirect calorimetry

    Time frame: 2 months

  4. postprandial plasma NEFA turnover

    will be determined using stable isotope tracers of fatty acids

    Time frame: 6 months

  5. postprandial plasma glucose turnover

    will be determined using stable isotope tracers of glucose

    Time frame: 6 months

  6. Left ventricular function by Positron Emitting Positron (PET) ventriculography

    will be determined using \[11C\]-acetate PET/CT. 180 megabecquerel (MBq) will be administered by bolus injection

    Time frame: 2 months

  7. Myocardial oxidative metabolism

    will be determined using i.v. \[11C\]-acetate during dynamic PET/CT scanning.

    Time frame: 2 months

  8. Insulin sensitivity

    will be determined using a multiplex ELISA which will measure multiple analytes in a single experiment.

    Time frame: 6 months

  9. Liver nonesterified fatty acids (NEFA) metabolism

    will be determined using \[11C\]-palmitate during dynamic PET acquisition.

    Time frame: 2 months

  10. Metabolites distribution in plasma

    will be determined using oral administration of \[18F\]-FTHA

    Time frame: 2 months

06

Study locations

1 of 1 sites recruiting
  • Centre de recherche du CHUS
    Sherbrooke, Quebec J1H 5N4, Canada
    Recruiting
07

Registry details

Key details

Study ID
NCT04227678
Lead sponsor
Université de Sherbrooke
Collaborators
Institut de Recherches Cliniques de Montreal
Responsible party
André Carpentier (tenured professor, Université de Sherbrooke) — Principal investigator
First posted
Jan 14, 2020
Start date
Dec 9, 2019
Primary completion
Dec 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Feb 10, 2026

Study contacts

Frédérique Frisch
Contact
frederique.frisch@usherbrooke.ca
819-346-1110- ext12394
André Carpentier
principal investigator · Université de Sherbrooke

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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