Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    35
  • sponsor
    University of Minnesota
Updated on 1 July 2021
antioxidants

Summary

The objective of this study is to evaluate oxidative stress and/or inflammation in patients with Gaucher disease type I using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.

Description

We will determine oxidative stress and/or inflammation related biomarkers in whole blood and/or plasma in adult subjects with Gaucher disease. Fifteen milliliter blood sample will be collected during three independent visits over a period of approximately 3 months. These samples will be processed to separate plasma from red blood cells and frozen until assays are performed. Standardized immunoassay methods and LC/MS based methods will be adopted to assay a series of biomarkers in these samples. These data will be correlated with currently used diagnostic biomarkers.

Details
Condition Stress, Inflammation, gaucher's disease, Gaucher Disease, Physiological Stress, Oxidative Stress
Clinical Study IdentifierNCT02437396
SponsorUniversity of Minnesota
Last Modified on1 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All participants must be 18 years or older
All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent
Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator
GD subjects must be stable on a specific ERT and/or SRT therapy at a specific dose (for e.g. on a units/kg basis) for at least 2 years or be nave to these therapies (no therapy for 2 years)
GD1 patients, who have had a change in therapy i.e. a change in dose or switch from one drug to another, can be enrolled after at least 6 months have elapsed since the change and is considered stable in the opinion of the clinician providing care to the patient
All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study

Exclusion Criteria

Medically unstable conditions in any group as determined by the investigators
Concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study
Unable to adhere to study protocol for whatever reason
Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception
History of asthma that is presently being treated
Subjects who cannot or are unwilling to have blood drawn
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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