Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults W… (NCT02502071) | Clinical Trial Compass
CompletedPhase 4
Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes
United States45 participantsStarted 2017-01
Plain-language summary
The purpose of this study is to determine whether alkalinization of urine uric acid by 2 doses of sodium bicarbonate (1950mg) over 24-hours reduces precipitation and crystallization of urine uric acid over in adults with type 1 diabetes.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (aged 18-45 years) with type 1 diabetes
* Participants must be able to be fasting prior to study visit and give informed consent.
Exclusion Criteria:
* Non-type 1 diabetes
* History of eGFR \<60 ml/min/1.73m2 or microalbuminuria or greater
* History of hypocalcemia or at risk of hypocalcemia
* Taking allopurinol or uric acid altering medications
* Ketogenic diet
* Ketonuria
* Taking phosphorus binders (e.g. sevelamer)
* Pregnant or breastfeeding
* Taking the following medications which may interact with sodium bicarbonate (e.g. phentermine, pseudoephedrine, antifungal medication, cephalosporin antibiotics \[e.g. Keflex\], tetracycline antibiotics \[e.g. doxycycline\], steroids or lithium)
* Taking SGLT-2 inhibitors
* Taking blood pressure medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether making urine more alkaline could reduce uric acid crystal buildup in people with Type 1 diabetes and kidney disease — since the trial is now completed, has any data been published, and what did it actually show about whether urinary alkalinization worked?
2The study measured uric acid precipitation using polarized microscopy and changes in uric acid solubility — do my own urine tests suggest I have uric acid crystals forming, and is that something worth monitoring given I have diabetic kidney disease?
3Since this was a Phase 4 trial testing an established approach in a specific population, does the evidence from this study change how you'd think about managing uric acid levels as part of protecting my kidneys?
4Urinary alkalinization can be achieved through diet or medications like sodium bicarbonate or potassium citrate — if this approach looks promising for my situation, what are the risks or side effects I should know about, especially with my kidneys already being affected by diabetes?
5Are there standard-of-care treatments for diabetic kidney disease that I should consider first, or is addressing uric acid crystallization something you'd want to tackle alongside those existing treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Urine Uric Acid Concentration (Increased Solubility) by Assay
Timeframe: Day 1 (pre-therapy) and Day 2 (post-therapy)
2
Change in Number of Participants With Urine Uric Acid Precipitation by Polarized Microscopy
Timeframe: Day 1 (pre-therapy) and Day 2 (post-therapy)