Phase 4 N=45 Treatment

Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes

Type 1 Diabetes · Diabetic Nephropathy · Diabetic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT02502071 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Change in Urine Uric Acid Concentration (Increased Solubility) by Assay — 23.81; 22.30 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: sodium bicarbonate (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Urine Uric Acid Concentration (Increased Solubility) by Assay	23.81; 22.30	—
PRIMARY Change in Number of Participants With Urine Uric Acid Precipitation by Polarized Microscopy	14; 3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02502071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.