Cutaneous Uric Acid and Metabolite Monitor System (UR+AIMS) Lab Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Evaluate tolerability and adherence of daily recorded patch wear time.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 with diagnosis of gout (screening positive ACR/EULAR Gout Classification Criteria - see screening survey) and eGFR > 60 (within the last 12-months).
- •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).
- •For the 5 patients with gout on urate-lowering therapy (ULT) [no dose change within the last 30 days].
排除标准
- •Contraindications to miosis, which include acute iritis, narrow-angle glaucoma
- •Known Hypersensitivity to pilocarpine hydrochloride
- •Pupillary block glaucoma (ophthalmic solution)
- •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).
结局指标
主要结局
Evaluate tolerability and adherence of daily recorded patch wear time.
时间窗: 3 years
Daily recorded patch wear time as recorded by mobile phone app.
Recording of uric acid (and oxypurinol) measurements while wearing patch.
时间窗: 3 years
Recording of uric acid (and other metabolites e.g., uric acid, oxypurinol, ethanol) measurements while wearing patch recorded by patch Bluetooth to mobile phone.
次要结局
未报告次要终点
研究者
John D. Fitzgerald, MD, PhD
Clin Prof, Clinical Chief
University of California, Los Angeles