Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease

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Conditions studied: Gaucher Disease Type I, Oxidative Stress, Inflammation

In brief

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.

Key facts

Study ID

NCT02437396

Run by

University of Minnesota

People needed

34

Starts

2015-10-01

Expected to finish

2026-10-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 naïve 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.

You may not qualify if…

• 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.
• 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
• Unable to adhere to study protocol for whatever reason

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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