Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
6 participants
INTERVENTIONAL
2025-03-10
2025-09-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Reliability of a Device (HumanSens Plus) Allowing Immediate Measurement Uric Acid in the Blood Obtained by Finger Tip Puncture.
NCT02671656
Treat-to-target by Email During Urate-lowering Therapy in Gout
NCT04733079
The Remote Monitoring of Gout Study
NCT06822933
Gout Self-Monitoring Aiming to Reach Target
NCT03274063
Virtual Gout Clinic
NCT02790463
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Patients will sign the informed consent, then answer some study questionnaires.
* The Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch and the study mobile device will be provided.
* Study nurse will start an IV for pre and post blood draws.
* Patients will be provided a standardized high-purine meal within 15 minutes. Pre-blood is drawn right before the patients eat the meal, then post-blood will be drawn every 15 minutes for the first hour after completion of the meal, then every 30 minutes for the next 3 hours (total of 4 hours).
* Then patients will be sent home with the skin patch and study mobile device.
Community 7-day observation period:
* Patients will be asked to apply a study patch each morning before their first meal of the day. The patch should be removed at the end of the day and put under water.
* The study device will monitor the patient's UA, glucose, heart rate, blood pressure, daily steps, and sleep. Patients will be asked to enter before and after meal uric acid levels and may be asked to take a picture of their meals using the study mobile device.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch
15 patients with gout will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch.
Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch
The intervention tested is the system (patch and mobile device/phone for reporting) that provides patients with better knowledge (test results) about the impact of their daily dietary choices on their uric acid levels.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch
The intervention tested is the system (patch and mobile device/phone for reporting) that provides patients with better knowledge (test results) about the impact of their daily dietary choices on their uric acid levels.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. For the 10 patients with gout off urate-lowering therapy (ULT) \[no Allopurinol, febuxostat, or probenecid prescription within the last 6-months\] and serum urate (SU) \> 7 mg/dL (within the last 12-months).
3. For the 5 patients with gout on urate-lowering therapy (ULT) \[no dose change within the last 30 days\].
Exclusion Criteria
2. Known Hypersensitivity to pilocarpine hydrochloride
3. Pupillary block glaucoma (ophthalmic solution)
4. Subjects reporting any allergy to glue or latex or any allergy to food that will be provided in the study (sardines in extra virgin olive oil and Sprite).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of California, Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John D. Fitzgerald, MD, PhD
Clin Prof, Clinical Chief
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John FitzGerald, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UR+AIMS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.