NCT02933138

Brief Summary

Purpose: The mechanism of most of the multifactorial chylomicronemia (MCM) remains elusive. In order to decipher the mechanisms involved in the occurrence of this disease, plasma TG lipolysis characteristics will be monitored for 60 minutes after heparin injection instead of the 10 minutes gold standard, in a large group of genotyped MCM patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 12, 2016

Last Update Submit

October 13, 2016

Conditions

Hyperlipoproteinemia

Keywords

Lipoprotein LipaseHypertriglyceridemiaTriglyceridesLipolysisMultifactorial Chylomicronemia

Outcome Measures

Primary Outcomes (1)

  • Lipoprotein Lipase concentration

    60 minutes after heparin injection

Secondary Outcomes (3)

  • Basal lipid profiles

    maximum 60 min before heparin injection

  • Lipoprotein electrophoresis

    maximum 60 minutes after heparin injection

  • Total triglycerides decrease

    maximum 60 minutes after heparin injection

Study Arms (1)

Multifactorial Chylomicronemia

no intervention, phenotypic and genotypic study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with a documented history of MCM (Plasma TG concentration (TG) \> 15 mmol/l or familial history of hypertriglyceridemia with TG \>10 mmol/l) who had no contraindication for a single heparin injection for ex vivo LPL activity assessment

You may qualify if:

  • patient with a documented history of MCM (Plasma TG concentration (TG) \> 15 mmol/l or familial history of hypertriglyceridemia with TG \>10 mmol/l)
  • no contraindication for a single heparin injection for ex vivo LPL activity assessment

You may not qualify if:

  • patients carriers of homozygous or compound heterozygous mutations on LPL, GPIHBP1, APOA5, APOC2 or APOE genes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

post-heparin EDTA plasma ADN

MeSH Terms

Conditions

HyperlipoproteinemiasHypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

March 1, 2015

Last Updated

October 14, 2016

Record last verified: 2016-10