Clinical trial NCT06187519: UR+AIMS Gout Wearable Skin Uric Acid Monitor Study
Official title: Cutaneous Uric Acid and Metabolite Monitor System (UR+AIMS) Lab Validation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gout
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-01-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility 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).

Primary outcomes:
measure: Evaluate tolerability and adherence of daily recorded patch wear time.
timeFrame: 3 years
measure: Recording of uric acid (and oxypurinol) measurements while wearing patch.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: John FitzGerald, MD
role: PRINCIPAL_INVESTIGATOR
References: