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Clinical Trials/NCT05046379
NCT05046379
Completed
Not Applicable

Lipidomics for Identification of New Biomarkers for Fabry Disease

Vastra Gotaland Region3 sites in 1 country108 target enrollmentOctober 14, 2021
ConditionsFabry Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fabry Disease
Sponsor
Vastra Gotaland Region
Enrollment
108
Locations
3
Primary Endpoint
Lipidomics
Status
Completed
Last Updated
last year

Overview

Brief Summary

Compare levels of lipids between well characterised enzymatically-genetically-phenotypically patients with Fabry disease and healthy controls (with no Fabry disease).

Correlate levels of lipids in patients with Fabry disease to clinical outcomes/manifestations of the disease.

Detailed Description

The hypothesis is that Sphingosine-1 Phosphate (S1P) or any other related sphingoid bases and/or other lipid class could be a marker of the severity of cardiovascular remodelling in Fabry disease. The overall approach is, by minimising possible pre-analytical and analytical biases, to study by lipidomics in well characterised enzymatically, genetically and phenotypically patients with Fabry disease, if S1P or any other lipid (including other glycosphingolipids) is shown to be a biomarker for the diagnosis, monitoring of disease activity and prognosis (including cardiovascular outcomes).

Registry
clinicaltrials.gov
Start Date
October 14, 2021
End Date
April 28, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Vastra Gotaland Region
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Lipidomics

Time Frame: Samples are going be collected during 1 year at the fasting state in the morning. At a random day in both Fabry patients with no treatment and cases. Up to 24 hours before next treatment in Fabry patients with ongoing treatment.

Lipid species from several lipid classes

Study Sites (3)

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