NCT02583672CompletedPhase 2
Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1)
Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1): Potential Use of Antioxidant/Anti-inflammatory Medications
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
The purpose of this study is to measure levels of blood and brain chemicals related to oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher disease (GD1) to see if these levels are altered by GD1.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 21 Aug 2015
- Start date
- Sept 2015
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Minnesota
- Diseases
- Gaucher disease
- NCT number
- NCT02583672
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 33
- From Sept 2015 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Medically unstable conditions in any group as determined by the investigators.
- History of asthma that is presently being treated.
- Allergy to N-acetylcysteine.
Age
- Women who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception.
Other
- Patients enrolled in another interventional study.
- Patients who cannot or are unwilling to have blood drawn.
- Inability to undergo MRI scanning, including but not limited to: unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs.
- Unable to adhere to study protocol for whatever reason.
Who the study is looking for
- All participants must be 18 years or older.
- All participants 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 GD1 who are medically stable for participation in the study in the opinion of the investigator.
- GD1 patients must be on a stable, specific ERT and/or SRT therapy at a specific dose (e.g. on a units/kg basis) for at least 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.
- Healthy subjects who will be frequency-matched for age.
- All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study and during the course of the study.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| New York University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.