Lipoprotein Lipase DeficiencyAGL12NCT04227678
Postprandial Fatty Acid Metabolism in Subjects With Lipoprotein Lipase Deficiency
A study testing Heparin and liquid meal in people with Lipoprotein Lipase Deficiency, run by Université de Sherbrooke at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoprotein Lipase Deficiency
- What is being tested?
- Heparin and liquid meal
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 9 Dec 2019to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4
Frédérique Frisch, 819-346-1110- ext12394, frederique.frisch@usherbrooke.ca
About this study
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.
- Conditions
- Lipoprotein Lipase Deficiency
- Being tested
- Heparin, liquid meal
- 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
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
liquid mealDietary supplement
low fat meal: (500 mL, 898 Kcal, 13% fat, 20.3% protein and 62.3% carbohydrates) will be ingested over 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control group- A0 | Other | 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 Receives: Dietary Supplement: liquid meal |
| LPLD group-A0 | Other | 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 Receives: Dietary Supplement: liquid meal |
| Control group-A1 | Other | 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. Receives: Drug: Heparin; Dietary Supplement: liquid meal |
| LPLD group-A1 | Other | 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. Receives: Drug: Heparin; Dietary Supplement: liquid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Myocardial DFA uptake
will be assessed using oral administration of [18F]-FTHA during dynamic PET acquisition.
Measured: 2 months
Secondary outcomes (10)
Myocardial nonesterified fatty acids (NEFA) metabolism
will be determined using [11C]-palmitate during dynamic PET acquisition.
Measured: 2 months
Dietary fatty acid oxidation rate
will be measured using breath [13C]-carbon dioxide enrichment
Measured: 6 months
Total oxidation rate
will be determined by indirect calorimetry
Measured: 2 months
postprandial plasma NEFA turnover
will be determined using stable isotope tracers of fatty acids
Measured: 6 months
postprandial plasma glucose turnover
will be determined using stable isotope tracers of glucose
Measured: 6 months
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
Measured: 2 months
Myocardial oxidative metabolism
will be determined using i.v. [11C]-acetate during dynamic PET/CT scanning.
Measured: 2 months
Insulin sensitivity
will be determined using a multiplex ELISA which will measure multiple analytes in a single experiment.
Measured: 6 months
Liver nonesterified fatty acids (NEFA) metabolism
will be determined using [11C]-palmitate during dynamic PET acquisition.
Measured: 2 months
Metabolites distribution in plasma
will be determined using oral administration of [18F]-FTHA
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start9 Dec 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
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 Université de SherbrookeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherches Cliniques de Montreal
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
- Investigators
- André Carpentier, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227678
- Sponsor's protocol ID
- 2019-2764
- Acronym
- AGL12
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Fatty Acid Metabolism in Subjects With Lipoprotein Lipase Deficiency
- ClinicalTrials.gov ID
- NCT04227678
- Acronym / sponsor ID
- AGL12 / 2019-2764
- Conditions
- Lipoprotein Lipase Deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Institut de Recherches Cliniques de Montreal
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 14 Jan 2020 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group- A0 | Other | Dietary Supplement: liquid mealControl 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 |
| LPLD group-A0 | Other | Dietary Supplement: liquid mealLPLD 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 |
| Control group-A1 | Other | Drug: Heparin, Dietary Supplement: liquid mealControl 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. |
| LPLD group-A1 | Other | Drug: Heparin, Dietary Supplement: liquid mealLPLD 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| Heparinan 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 | Control group-A1, LPLD group-A1 |
| liquid meallow fat meal: (500 mL, 898 Kcal, 13% fat, 20.3% protein and 62.3% carbohydrates) will be ingested over 20 minutes | Dietary supplement | Control group- A0, Control group-A1, LPLD group-A0, LPLD group-A1 |
Primary outcome
Organ-specific Dietary Fatty Acid (DFA) partitioning
Time frame: 2 months
will be determined using oral administration of [18F ]-Fluoro-6-Thia- Heptadecanoic Acid (FTHA ) during whole-body acquisition.
Myocardial DFA uptake
Time frame: 2 months
will be assessed using oral administration of [18F]-FTHA during dynamic PET acquisition.
10 secondary outcomes
Myocardial nonesterified fatty acids (NEFA) metabolism
Time frame: 2 months
Dietary fatty acid oxidation rate
Time frame: 6 months
Total oxidation rate
Time frame: 2 months
postprandial plasma NEFA turnover
Time frame: 6 months
postprandial plasma glucose turnover
Time frame: 6 months
Left ventricular function by Positron Emitting Positron (PET) ventriculography
Time frame: 2 months
Myocardial oxidative metabolism
Time frame: 2 months
Insulin sensitivity
Time frame: 6 months
Liver nonesterified fatty acids (NEFA) metabolism
Time frame: 2 months
Metabolites distribution in plasma
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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.
André Carpentier principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin and liquid meal in people with Lipoprotein Lipase Deficiency, run by Université de Sherbrooke at 1 site in Canada.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédérique Frisch (819-346-1110- ext12394, frederique.frisch@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ-specific Dietary Fatty Acid (DFA) partitioning (time frame: 2 months). The study lists 2 primary outcomes in all. 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 10 Feb 2026.