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UR+AIMS Gout Wearable Skin Uric Acid Monitor Study

Study Purpose

15 patients with gout [10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)] 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age > 18 with diagnosis of gout (screening positive ACR/EULAR Gout Classification Criteria
  • - see screening survey) and eGFR > 60 (within the last 12-months).
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:

1. Contraindications to miosis, which include acute iritis, narrow-angle glaucoma. 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06187519
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, Los Angeles
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 John FitzGerald, MD
Principal Investigator Affiliation University of California, Los Angeles
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Gout
Additional Details

First Visit at the UCLA Human Nutrition Center:

  • - 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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Device: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCLA, Los Angeles, California

Status

Address

UCLA

Los Angeles, California, 90095

Site Contact

John FitzGerald, MD

[email protected]

310-825-2448

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