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Clinical Trials/NCT04201067
NCT04201067
Completed
Not Applicable

Large-Scale Metabolomic Profiling for the Diagnosis of Inborn Errors of Metabolism

Mayo Clinic1 site in 1 country240 target enrollmentOctober 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Disorders of Glycosylation
Sponsor
Mayo Clinic
Enrollment
240
Locations
1
Primary Endpoint
Develop quantitative biomarkers for PGM1-CDG patients to monitor the efficacy of galactose therapy.
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

Researchers are trying to determine the efficacy of a global metabolomic approach in testing for and diagnosing inborn errors of metabolism as opposed to traditional testing methods.

Detailed Description

Residual samples will be tested for a variety of biomarkers that may lead to better understanding of these disorders and help develop treatment options.

Registry
clinicaltrials.gov
Start Date
October 8, 2019
End Date
March 12, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David R. Deyle

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • All individuals with specimens in Biochemical Genetics Laboratory and from patients collected under another IRB who have agreed to share samples/data

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Develop quantitative biomarkers for PGM1-CDG patients to monitor the efficacy of galactose therapy.

Time Frame: length of study, up to 5 years

Measure the 41 plasma N-glycan levels in 9 PGM1-CDG patients before and after galactose therapy.

Develop quantitative biomarkers for SLC35A2-CDG patients and monitor galactose therapy efficacy.

Time Frame: length of study, up to 5 years

Measure levels of plasma N-glycans from 10 SLC35A2-CDG patients before and after galactose therapy.

Quantify N-linked glycan intermediates in plasma and urine

Time Frame: length of study, up to 5 years

Measure N-linked glycan intermediates in plasma and urine from PMM2-CDG patients.

Validate biomarker to diagnose and follow NGLY1 deficiency and monitor N-acetylglucosamine (GlcNAc) therapy response.

Time Frame: length of study, up to 5 years

Measure the level of Sia-Gal-GlcNAc-Asn biomarker excretion during GlCNAc therapy.

Validate novel diagnostic biomarkers for ALG13-CDG

Time Frame: length of study, up to 5 years

Measure GlcNAc-β-Asn on glycoproteins in the cells from the already available fibroblast of 9 ALG13 patients.

Study Sites (1)

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