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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06187519
Other study ID # UR+AIMS
Secondary ID R21DK132666
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 30, 2024
Est. completion date February 1, 2028

Study information

Verified date April 2024
Source University of California, Los Angeles
Contact John FitzGerald, MD
Phone 310-825-2448
Email JFitzgerald@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date February 1, 2028
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States UCLA Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate tolerability and adherence of daily recorded patch wear time. Daily recorded patch wear time as recorded by mobile phone app. 3 years
Primary Recording of uric acid (and oxypurinol) measurements while wearing patch. Recording of uric acid (and other metabolites e.g., uric acid, oxypurinol, ethanol) measurements while wearing patch recorded by patch Bluetooth to mobile phone. 3 years
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