[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02437396":3,"trial-entities:NCT02437396":78,"trial-summary:NCT02437396":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":38,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":72,"overall_officials":74,"references":76,"see_also_links":77},"NCT02437396","1305M34501","Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease","Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)","RECRUITING","2026-10-30","2026-07","2026-07-13","2015-10","University of Minnesota","OTHER",false,"The objective of this study is to evaluate oxidative stress and\u002For inflammation in patients with Gaucher disease type I using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.","We will determine oxidative stress and\u002For inflammation related biomarkers in whole blood and\u002For 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\u002FMS based methods will be adopted to assay a series of biomarkers in these samples. These data will be correlated with currently used diagnostic biomarkers.",[19,20,21],"Gaucher Disease Type I","Oxidative Stress","Inflammation",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},34,"ESTIMATED",[],[31,35],{"measure":32,"description":33,"timeFrame":34},"Change in Plasma C5a Concentration","Outcome will be reported as the change in plasma concentration of C5a (ng\u002Fml) from baseline to 6 months in participants with Gaucher disease type 1","6 months",{"measure":36,"description":37,"timeFrame":34},"Change in Plasma Hepcidin Concentration","Outcome will be reported as the change in plasma concentration of hepcidin (ng\u002Fml) from baseline to 6 months in participants with Gaucher disease type 1",[39,42],{"measure":40,"description":41,"timeFrame":34},"Change in Blood Glutathione Concentration","Outcome will be reported as the change in blood concentration of glutathione (umol\u002Fg) from baseline to 6 months in participants with Gaucher disease type 1",{"measure":43,"description":44,"timeFrame":34},"Change in Plasma Tumor Necrosis Factor (TNF)-alpha Concentration","Outcome will be reported as the change in blood concentration of TNF-alpha (pg\u002Fml) from baseline to 6 months in participants with Gaucher disease type 1","ALL","18 Years","75 Years",{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Inclusion criteria:\n\n1. All participants must be 18 years or older.\n2. 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.\n3. Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator.\n4. GD subjects must be stable on a specific ERT and\u002For SRT therapy at a specific dose (for e.g. on a units\u002Fkg basis) for at least 2 years or be naïve to these therapies (no therapy for 2 years).\n5. 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.\n6. All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.\n\nExclusion Criteria:\n\n1. Medically unstable conditions in any group as determined by the investigators\n2. 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.\n3. Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception\n4. History of asthma that is presently being treated\n5. Subjects who cannot or are unwilling to have blood drawn\n6. Unable to adhere to study protocol for whatever reason",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":13,"status":8,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":69},"Minneapolis","Minnesota","55455","United States",[62,67],{"name":63,"role":64,"phone":65,"email":66},"Reena Kartha, PhD","CONTACT","612-626-2436","rvkartha@umn.edu",{"name":63,"role":68},"PRINCIPAL_INVESTIGATOR",{"lat":70,"lon":71},44.97997,-93.26384,[73],{"name":63,"role":64,"phone":65,"email":66},[75],{"name":63,"affiliation":13,"role":68},[],[],{"nct_id":4,"conditions":79,"biomarkers":81},[80],"Gaucher's disease, type I",[],{"nct_id":4,"found":83,"summary":84,"prompt_version":94},true,{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an observational study planning to enroll 34 participants. It is not testing a new treatment, but rather observing certain health markers.","completed","Observational Study of Oxidative Stress and Inflammation in Gaucher Disease Type I","This study is looking at how oxidative stress (an imbalance between free radicals and antioxidants in your body) and inflammation (your body's response to injury or infection) are involved in Gaucher disease type I. Researchers will measure different markers in your blood to see if they can be used to understand these processes better. You may be able to join if you are an adult with Gaucher disease type I, between 18 and 75 years old, and are medically stable. The study aims to see if changes in specific blood markers, like C5a and Hepcidin, are present after 6 months. The current status of this study is unclear.","Changes in certain blood markers will be measured at 6 months.",108,"You would provide 15 milliliters of blood during three separate visits over approximately 3 months. These samples will be used to measure various biomarkers.","Not stated in the trial record.",[],"v2"]