Plasma Triglyceride Lipolysis in Multifactorial Chylomicr... | NCT02933138

Studies
Plasma Triglyceride Lipolysis in Multifactorial Chylomicronemia

NCT02933138

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Oct 14, 2016Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Hyperlipoproteinemia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Mar 2015Actual

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 13, 2016

First Posted Date

Oct 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Description Module

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.

Detailed Description

Method: LPL, APOC2, APOA5, GPIHB1and APOE genotypes will be determined for each patient. Basal lipid profiles including Apo B, CII, CIII, and lipoprotein lipase (LPL) concentration will be measured in 62 MCM patients, in addition to LPL activity (PHLA) T0, T10 T30 T60 minutes, Assessment of TG chylomicron decrease Study of lipoprotein remodelling by agarose gel electrophoresis.

Hypothesis To confirm the preliminary finding of high LPL activity in multifactorial chylomicronemia To explore the interest of a longer assessment of LPL activity following heparin injection. To establish if specific phenotypes could be identified among MCM patient supporting the hypothesis of different mechanisms involved (ie overproduction or defect in hepatic clearance)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multifactorial Chylomicronemia		no intervention, phenotypic and genotypic study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lipoprotein Lipase concentration		60 minutes after heparin injection

Secondary Outcomes

Measure	Description	Time Frame
Basal lipid profiles		maximum 60 min before heparin injection
Lipoprotein electrophoresis		maximum 60 minutes after heparin injection
Total triglycerides decrease

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006951	Hyperlipoproteinemias
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

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Browse Branches

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