Trial Outcomes & Findings for Uric Acid Lowering Trial in Youth Onset T2D (NCT NCT03899883)
NCT ID: NCT03899883
Last Updated: 2026-07-28
Results Overview
Systolic blood pressure measured by sphygmomanometer
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline and 1 week post treatment
Results posted on
2026-07-28
Participant Flow
Recruitment over 2-year study period (study start through completion of N=10 enrollment), targeting up to 14 men aged 18-35 with youth-onset T2D (diagnosis ≤ 25 yrs) and SUA ≥5 mg/dL. Participants are recruited from three clinical sites at the University of Colorado Anschutz Medical Campus: the Barbara Davis Center for Childhood Diabetes, the adult diabetes clinic at University of Colorado Hospital, and the pediatric T2D clinic at Children's Hospital Colorado.
Participant milestones
| Measure |
Men With Youth-onset T2D
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
|
9
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|
Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uric Acid Lowering Trial in Youth Onset T2D
Baseline characteristics by cohort
| Measure |
Men With Youth-onset T2D
n=11 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Age, Continuous
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22 Years
STANDARD_DEVIATION 5 • n=20 Participants
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Sex: Female, Male
Female
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0 Participants
n=20 Participants
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Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
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1 Participants
n=20 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
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Race (NIH/OMB)
Black or African American
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1 Participants
n=20 Participants
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Race (NIH/OMB)
White
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6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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8 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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3 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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Mean arterial pressure
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98 mmHg
STANDARD_DEVIATION 10 • n=20 Participants
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentSystolic blood pressure measured by sphygmomanometer
Outcome measures
| Measure |
Men With Youth-onset T2D
n=11 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Systolic Blood Pressure
1 week post treatment
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85 mmHg
Standard Deviation 11
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Systolic Blood Pressure
Baseline
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80 mmHg
Standard Deviation 12
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentDiastolic blood pressure measured by sphygmomanometer
Outcome measures
| Measure |
Men With Youth-onset T2D
n=11 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Diastolic Blood Pressure
Baseline
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135 mmHg
Standard Deviation 13
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Diastolic Blood Pressure
1 week post treatment
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132 mmHg
Standard Deviation 9
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentMean arterial pressure measured by sphygmomanometer
Outcome measures
| Measure |
Men With Youth-onset T2D
n=11 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Mean Arterial Pressure
Baseline
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98 mmHg
Standard Deviation 10
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Mean Arterial Pressure
1 week post treatment
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101 mmHg
Standard Deviation 10
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentMeasured by Aortic MRI renal MRI (4D Flow)
Outcome measures
| Measure |
Men With Youth-onset T2D
n=11 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Pulse Wave Velocity (PWV)
Baseline
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4.8 m/s
Standard Deviation 1.3
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Pulse Wave Velocity (PWV)
1 week post surgery
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4.3 m/s
Standard Deviation 0.8
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentMeasured by Aortic MRI renal MRI (4D Flow)
Outcome measures
| Measure |
Men With Youth-onset T2D
n=11 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Wall Shear Stress (WSS)
Baseline
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1.2 Pa
Standard Deviation 0.16
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Wall Shear Stress (WSS)
1 week post treatment
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1.1 Pa
Standard Deviation 0.10
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentMeasured by 4D Flow renal MRI
Outcome measures
| Measure |
Men With Youth-onset T2D
n=9 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Renal Blood Flow
Baseline
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18.4 mL/cycle
Standard Deviation 5.0
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Renal Blood Flow
1 week post treatment
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18.2 mL/cycle
Standard Deviation 5.3
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentMeasured by Iohexol Clearance in Plasma
Outcome measures
| Measure |
Men With Youth-onset T2D
n=9 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Glomerular Filtration Rate
1 week post treatment
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122 mL/min/1.73m^2
Standard Deviation 19
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Glomerular Filtration Rate
Baseline
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113 mL/min/1.73m^2
Standard Deviation 20
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PRIMARY outcome
Timeframe: Baseline and 1 week post treatmentMeasured by albumin and creatinine concentrations in urine
Outcome measures
| Measure |
Men With Youth-onset T2D
n=9 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Urine Albumin-creatinine Ratio
Baseline
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18 mg/g
Interval 9.0 to 578.0
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Urine Albumin-creatinine Ratio
1 week post treatment
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21 mg/g
Interval 6.0 to 211.0
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SECONDARY outcome
Timeframe: Baseline and 1 week post treatmentMeasured by baseline sUA compared to sUA one week later
Outcome measures
| Measure |
Men With Youth-onset T2D
n=9 Participants
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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Serum Uric Acid (sUA)
Baseline
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6.4 mg/dL
Interval 6.0 to 7.3
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Serum Uric Acid (sUA)
1 week post treatment
|
0.5 mg/dL
Interval 0.5 to 4.6
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Adverse Events
Men With Youth-onset T2D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Men With Youth-onset T2D
n=11 participants at risk
Adult men aged 18-35 years with youth-onset type 2 diabetes (diagnosed at ≤ 25 years of age) and serum uric acid ≥ 5mg/dL. Participants received a single intravenous dose of pegloticase (Krystexxa) 8 mg in 250 mL of 0.9% normal saline, infused slowly over ≥120 minutes.
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|---|---|
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General disorders
Pegloticase Infusion Reaction
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18.2%
2/11 • Baseline to 1 week post treatment
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General disorders
Back and neck pain
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9.1%
1/11 • Baseline to 1 week post treatment
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Metabolism and nutrition disorders
Post-infusion hyperglycemia requiring insulin administration
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9.1%
1/11 • Baseline to 1 week post treatment
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Injury, poisoning and procedural complications
Superficial blood clot after IV placement
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9.1%
1/11 • Baseline to 1 week post treatment
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Gastrointestinal disorders
GI discomfort
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9.1%
1/11 • Baseline to 1 week post treatment
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General disorders
Weakness
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9.1%
1/11 • Baseline to 1 week post treatment
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Additional Information
Petter Bjornstad, MD
University of Washington; University of Colorado Anschutz Medical Campus
Phone: 206-616-3543
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place