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New Treatment for Lipoprotein Lipase Deficiency (AGL12 Trial)

N/A
Recruiting
Led By André Carpentier
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 75 years old
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

AGL12 Trial Summary

This trial is testing a new treatment for lipoprotein lipase deficiency, which is a condition that causes high triglyceride levels in the blood. The new treatment is designed to help the body clear triglycerides from the blood.

Who is the study for?
This trial is for adults aged 18-75 with Lipoprotein Lipase Deficiency (LPLD), evidenced by high fasting triglyceride levels and specific gene mutations. Healthy individuals with normal blood sugar and triglyceride levels can also join as controls. Participants must not have cardiovascular disease, a history of certain blood disorders or be on medications affecting lipid metabolism.Check my eligibility
What is being tested?
The study investigates how LPLD affects the body's handling of dietary fats after eating, specifically looking at fat storage in tissues and its use as fuel for heart function. It involves administering heparin and a liquid meal to understand these metabolic processes in both LPLD patients and healthy controls.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site from heparin, increased risk of bleeding due to heparin's blood-thinning properties, and possible gastrointestinal symptoms following the liquid meal.

AGL12 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.
Select...
I have LPL deficiency with high fasting triglycerides and a confirmed LPL gene mutation.

AGL12 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Myocardial DFA uptake
Organ-specific Dietary Fatty Acid (DFA) partitioning
Secondary outcome measures
Dietary fatty acid oxidation rate
Insulin sensitivity
Left ventricular function by Positron Emitting Positron (PET) ventriculography
+7 more

AGL12 Trial Design

4Treatment groups
Experimental Treatment
Group I: LPLD group-A1Experimental Treatment2 Interventions
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.
Group II: LPLD group-A0Experimental Treatment1 Intervention
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
Group III: Control group-A1Experimental Treatment2 Interventions
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.
Group IV: Control group- A0Experimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heparin
2003
Completed Phase 4
~22600
liquid meal
2015
N/A
~70

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
290 Previous Clinical Trials
68,929 Total Patients Enrolled
Institut de Recherches Cliniques de MontrealOTHER
70 Previous Clinical Trials
10,352 Total Patients Enrolled
André CarpentierPrincipal InvestigatorUniversité de Sherbrooke
2 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Control group- A0 Clinical Trial Eligibility Overview. Trial Name: NCT04227678 — N/A
Lipoprotein Lipase Deficiency Research Study Groups: Control group- A0, LPLD group-A0, Control group-A1, LPLD group-A1
Lipoprotein Lipase Deficiency Clinical Trial 2023: Control group- A0 Highlights & Side Effects. Trial Name: NCT04227678 — N/A
Control group- A0 2023 Treatment Timeline for Medical Study. Trial Name: NCT04227678 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research opportunity include young adults?

"This trial is only looking for patients between 18-75 years of age. There are 4 other clinical trials that cater to patients below the age of majority and 45 trials for senior citizens."

Answered by AI

What are researchers hoping to learn from this clinical trial?

"The purpose of this two-month study is to understand how dietary fat affects different organs. To do so, we will be measuring postprandial plasma NEFA turnover, Dietary fatty acid oxidation rate, and Total oxidation rate."

Answered by AI

How many people are allowed to enroll in this clinical trial?

"The clinical trial is admitting 16 participants at 1 site."

Answered by AI

Is this a groundbreaking or innovative trial?

"As of now, there are 44 ongoing clinical trials worldwide for this treatment across 210 cities and 23 countries. The first trial was held in 2006 and completed Phase 3 drug approval in the same year. 415 people participated in the trial sponsored by Ash Access Technology. In the years since 2006, 192 similar studies have been completed."

Answered by AI

What are the typical conditions that this therapy is designed to address?

"This treatment is often used for medical devices, but it can also help patients with conditions like atrial fibrillation, sprains, and unstable angina pectoris."

Answered by AI

Who can join this medical study?

"This study is looking for 16 individuals that meet the following criteria: age 18 to 75 years old, lipoprotein lipase, and a willingness to adhere to the protocol."

Answered by AI

Are investigators looking for more participants at this time?

"Correct, the clinical trial is currently underway with a goal of recruiting 16 patients from 1 location. The information on clinicaltrials.gov shows that this trial was first posted on December 9th, 2019 and was last updated on September 27th, 2022."

Answered by AI

Does this therapy have a history of being tested in other medical trials?

"As of right now, there are 44 on-going trials for this particular treatment. Out of these, 15 have reached Phase 3 status. Most studies related to this medication are based in Sherbrooke, Quebec; however, 388 research centres across the globe are currently investigating this topic."

Answered by AI
~1 spots leftby Jul 2024