Who may be eligible for the Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease trial?

Inclusion criteria: 1. All participants must be 18 years or older. 2. 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. 3. Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator. 4. 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). 5. 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. 6. All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study. Exclusion Criteria: 1. Medically unstable conditions in any group as determined by the investigators 2. 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. 3. Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception 4. History of asthma that is presently being treated 5. Subjects who cannot or are unwilling to have blood drawn 6. Unable to adhere to study protocol for whatever reason

ClinicalTrials.gov record NCT02437396

Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an observational, case-control study that measures oxidative stress and inflammatory biomarkers in adults with Gaucher disease type 1. Participants give blood at three visits over about three months; samples are frozen and later tested using immunoassay and LC/MS methods. The study includes people with GD1 (treatment‑naive or stable on therapy) and age-matched healthy controls, but the registry says the healthy-volunteer group is no longer enrolling new participants.

What it is studying. The study is testing whether blood markers of oxidative stress and inflammation — including plasma C5a, hepcidin, glutathione, and TNF‑alpha — can be measured and how those measurements relate to currently used diagnostic biomarkers in adults with Gaucher disease type 1.

What the researchers hope to learn. To evaluate oxidative stress and inflammation-related biomarkers in blood of adults with Gaucher disease type 1; to measure changes in plasma C5a and hepcidin (and other markers) from baseline to six months; and to correlate these biomarkers with currently used diagnostic markers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 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.

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.
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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Provide written informed consent and attend three separate clinic visits over about three months. At each visit a 15 mL blood sample will be taken; samples are processed (plasma and red blood cells) and frozen for lab assays. The study uses standardized immunoassays and LC/MS methods to measure biomarkers and will compare those results with existing diagnostic biomarkers. Participants must avoid the listed antioxidant supplements for three weeks before enrollment; no other invasive procedures are specified in the registry.

How the study is structured. Observational, prospective case-control study. Adults with Gaucher disease type 1 (treatment‑naive or stable on a specific ERT/SRT dose) and age-matched healthy controls give a 15 mL blood sample at three visits across approximately three months. Samples will be processed, frozen, and later analyzed by standardized immunoassays and LC/MS-based methods to compare biomarker levels between groups and over time.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: October 2015
Primary completion: Oct 30, 2026 (estimated)
Study completion: Oct 30, 2026 (estimated)
Target enrollment: 34 participants (estimated)
Last updated on registry: Jul 13, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: University of Minnesota

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Reena Kartha, PhD 📞 612-626-2436 ✉ rvkartha@umn.edu

Participating sites (1)

University of MinnesotaRecruiting
Minneapolis, Minnesota, 55455 · United States
- Reena Kartha, PhD · 612-626-2436 · rvkartha@umn.edu
- Reena Kartha, PhD

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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