Actively Recruiting
Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)
Led by University of Minnesota · Updated on 2026-03-19
34
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying oxidative stress and inflammation in adults with Gaucher disease type I by measuring various biomarkers. The goal is to understand how these biomarkers relate to current diagnostic tests used for this condition. This observational study includes adults aged 18 to 75 who are either treatment-naive or stable on enzyme replacement or substrate reduction therapy. Participants will provide 15 milliliters of blood during three separate visits over about three months. Blood samples will be processed to separate plasma and red blood cells, then frozen for later analysis using standardized immunoassays and LC/MS methods. The study includes groups of treatment-naive Gaucher disease patients, those stable on therapy for at least two years, and age-matched healthy controls, although no new healthy controls will be enrolled. During the study, researchers will assess changes in plasma C5a and hepcidin concentrations over six months as primary outcomes. Secondary outcomes include changes in blood glutathione and plasma TNF-alpha levels. Participants will be monitored for stability and ability to comply with study requirements, with assessments including blood sample collections and reviewing therapy status. The study's total duration for each participant spans approximately three months with multiple visits for sample collection and monitoring.
CONDITIONS
Brief Title
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older
- Must understand and cooperate with study requirements and provide written informed consent
- Individuals with Gaucher disease who are medically stable for participation
- Gaucher disease subjects must be either stable on specific enzyme replacement therapy (ERT) and/or substrate reduction therapy (SRT) at a fixed dose for at least 2 years or have not received these therapies for 2 years
- Patients with therapy changes must be stable for at least 6 months after change
- No antioxidants like coenzyme Q-10, vitamin C, or vitamin E taken for 3 weeks prior to study
You will not qualify if you...
- Medically unstable conditions as determined by investigators
- Concurrent diseases or conditions that may compromise safety, study compliance, or data integrity
- Females who are pregnant, lactating, or of child-bearing age not using acceptable contraception
- History of currently treated asthma
- Unable or unwilling to have blood drawn
- Unable to adhere to study protocol for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 months
Participants provide blood samples to measure oxidative stress and inflammation-related biomarkers.
3 visits for blood sample collection
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
R
Reena Kartha, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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