Trial Outcomes & Findings for Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes (NCT NCT02502071)
NCT ID: NCT02502071
Last Updated: 2022-01-24
Results Overview
Urine uric acid were evaluated using a QuantiChrom UA kit assay (DIUA-250) with quantitative colorimetric UA determination at 590 nm (BioAssay System, California, USA).
COMPLETED
PHASE4
45 participants
Day 1 (pre-therapy) and Day 2 (post-therapy)
2022-01-24
Participant Flow
Participant milestones
| Measure |
Sodium Bicarbonate
All participants will receive 2 doses of 1950mg Sodium Bicarbonate
sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Sodium Bicarbonate
n=45 Participants
All participants will receive 2 doses of 1950mg Sodium Bicarbonate
sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate
|
|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Type 1 Diabetes Duration
|
20.2 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-therapy) and Day 2 (post-therapy)Urine uric acid were evaluated using a QuantiChrom UA kit assay (DIUA-250) with quantitative colorimetric UA determination at 590 nm (BioAssay System, California, USA).
Outcome measures
| Measure |
Sodium Bicarbonate
n=45 Participants
All participants will receive 2 doses of 1950mg Sodium Bicarbonate
sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate
|
|---|---|
|
Change in Urine Uric Acid Concentration (Increased Solubility) by Assay
Day 1 (pre-therapy)
|
23.81 mg/dl
Interval 18.93 to 29.94
|
|
Change in Urine Uric Acid Concentration (Increased Solubility) by Assay
Day 2 (post-therapy)
|
22.30 mg/dl
Interval 17.63 to 28.2
|
PRIMARY outcome
Timeframe: Day 1 (pre-therapy) and Day 2 (post-therapy)Urine uric acid crystals were identified by polarized microscopy (Polarized light imaging Zeiss Axiovert 135; 0.3NA objective), and pictures were captured from each urine sample. UA crystals were defined dichotomously as being present or absent.
Outcome measures
| Measure |
Sodium Bicarbonate
n=45 Participants
All participants will receive 2 doses of 1950mg Sodium Bicarbonate
sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate
|
|---|---|
|
Change in Number of Participants With Urine Uric Acid Precipitation by Polarized Microscopy
Day 1 (pre-therapy)
|
14 participants
|
|
Change in Number of Participants With Urine Uric Acid Precipitation by Polarized Microscopy
Day 2 (post-therapy)
|
3 participants
|
Adverse Events
Sodium Bicarbonate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sodium Bicarbonate
n=45 participants at risk
All participants will receive 2 doses of 1950mg Sodium Bicarbonate
sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate
|
|---|---|
|
Endocrine disorders
Hypoglycemia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected while the participant was in the trial (24-36 hours)
|
Additional Information
Dr. Petter Bjornstad, Assistant Professor
University of Colorado School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place