Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by John FitzGerald, MD
Headshot of John FitzGerald
John FitzGerald

Description

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.

Official Title

Cutaneous Uric Acid and Metabolite Monitor System (UR+AIMS) Lab Validation

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.

Keywords

Gout, Uric Acid, Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch

Eligibility

You can join if…

Open to people ages 18 years and up

  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].

You CAN'T join if...

  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).

Location

  • UCLA
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • John FitzGerald, MD
    Professor of Clinical, Medicine. Authored (or co-authored) 40 research publications. Research interests: Gout · CPPD · Ultrasound · Synovial fluid · Knee Replacement · Health Disparities

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06187519
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated