Trial · NCT02583672
Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1)
NCT02583672, Phase 2, Completed, University of Minnesota
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1). Trials, record NCT02583672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02583672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1)
- NCT number
- NCT02583672
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Gaucher Disease Type 1
- Interventions
- N-acetylcysteine
- First posted
- 2015-10-22
- Last updated
- 2026-02-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in subjects with Gaucher disease type 1, in concentration of glutathione in brain (μmol/g) | At 90 days and at 180 days | The investigators will measure the concentration of glutathione (GSH) in the brains of subjects with Gaucher disease type 1 at 90 days after enrollment, which is the baseline measure. It will again be measured at 180 days after enrollment. These measures will be obtained using NMR spectroscopy (often referred to by the acronym "MRS"). The MRS study will take place over approximately 1.0 hour and will generate measurements of GSH levels from 2-3 brain regions. Scanning may be done in multiple sessions if needed, but will not exceed 1.5 total scanning hours. |
| Secondary | In healthy volunteers, determination of level of glutathione in brain (μmol/g) | 90 Days After Enrollment | The investigators will measure the glutathione (GSH) level in the brains of healthy volunteers at 90 days after enrollment. This measure will be obtained using MRS. The MRS study will take place over approximately 1.0 hour and will generate measurements of GSH levels from 2-3 brain regions. Scanning may be done in multiple sessions if needed, but will not exceed 1.5 total scanning hours. |
| Secondary | Change in subjects with Gaucher disease type 1, in concentration of glutathione in blood (μmol/g) | Baseline, 45 days, 90 days, 120 days, 150 days, 180 days, and 270 days | Investigators will measure the glutathione concentration in the blood of subjects with Gaucher disease type 1, at baseline (enrollment), 45 days, 90 days, 120 days, 150 days, 180 days, and 270 days. Blood samples will be drawn and analyzed using liquid chromatography-tandem mass spectrometry ("LC-MS"). |
| Secondary | Change in healthy volunteers, in concentration of glutathione in blood (μmol/g) | Baseline, 45 days, and 90 days | Investigators will measure the concentration of glutathione in the blood of healthy volunteers at baseline, at 45 days, and at 90 days. Blood samples will be drawn and analyzed using LC-MS. |
| Secondary | Change in subjects with Gaucher disease type 1, in concentration of myo-inositol in brain (μmol/g) | At 90 days and at 180 days | The investigators will measure the concentration of myo-inositol in brains of subjects with Gaucher disease type 1 at 90 days after enrollment, which is the baseline measure. It will again be measured at 180 days after enrollment. These measures will be obtained using MRS. The MRS study will take place over approximately 1.0 hour and will generate measurements of myo-inositol levels from 2-3 brain regions. Scanning may be done in multiple sessions if needed, but will not exceed 1.5 total scanning hours. These measures will be performed concurrently during the MRS scans being performed to measure GSH levels. |
| Secondary | In healthy volunteers, determine the concentration of myo-inositol in brain (μmol/g) | 90 Days After Enrollment | The investigators will measure the concentration of myo-inositol in brains of healthy volunteers at 90 days after enrollment. This measure will be obtained using MRS. The MRS study will take place over approximately 1.0 hour and will generate measurements of myo-inositol levels from 2-3 brain regions. Scanning may be done in multiple sessions if needed, but will not exceed 1.5 total scanning hours. This measure will be performed concurrently during the MRS scan being performed to measure GSH level. |
| Secondary | Change in subjects with Gaucher disease type 1, in concentration of TNF-alpha in plasma (pg/mL) | Baseline, 45 days, 90 days, 120 days, 150 days, 180 days, and 270 days | The investigators will measure the concentration of TNF-alpha in blood of subjects with Gaucher disease type 1 at baseline (enrollment), 45 days, 90 days, 120 days, 150 days, 180 days, and 270 days. Blood samples will be drawn and analyzed using immunoassay for TNF-alpha. |
| Secondary | Change in healthy volunteers, in concentration of TNF-alpha in plasma (pg/mL) | Baseline, 45 days, and 90 days | The investigators will measure the concentration of TNF-alpha in blood of healthy volunteers at baseline (enrollment), at 45 days, and at 90 days. Blood samples will be drawn and analyzed using immunoassay for TNF-alpha. |
| Secondary | Change in subjects with Gaucher disease type 1, in concentration of N-acetylcysteine (NAC) in blood (µg/ml) | 120 days, 150 days, and 180 days | Investigators will measure NAC levels in the blood of subjects with Gaucher disease type 1, at 120 days after enrollment, 150 days, and 180 days. Blood samples will be drawn and analyzed using LC-MS. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54NS065768 | Lysosomal Disease Network | WHITLEY, CHESTER B. | UNIVERSITY OF MINNESOTA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2009 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02583672
GET https://conductscience.org/api/trials/v1/NCT02583672/registered