Uric Acid Lowering Trial in Youth Onset T2D
Phase 2
Completed
NCT03899883
| Condition | Diabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2 |
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| Phase | Phase 2 |
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| Sponsor | University of Colorado, Denver |
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| Status | Completed |
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| Enrollment | 11 participants |
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| Interventions | Pegloticase 8 MG/ML [Krystexxa] |
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| Start date | Jan 1, 2020 |
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| Completion date | Apr 13, 2023 |
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| Results posted | Jul 28, 2026 |
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Summary
Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. The investigators also recently demonstrated that higher SUA conferred greater odds of developing hypertension and diabetic kidney disease (DKD) in youth with T2D over 7 years follow-up. Elevated SUA is thought to lead to cardiovascular disease (CVD) and DKD by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. While there are studies demonstrating beneficial effects of uric acid (UA) lowering on vascular health in the general population, there are no studies in youth-onset T2D. Youth-onset T2D carries a greater risk of DKD and CVD compared to adult-onset T2D and T1D. Accordingly, a clinical trial evaluating UA lowering therapies is needed in youth-onset T2D. Krystexxa (pegloticase), a uricase, effectively lowers SUA and therefore holds promise as a novel therapy to impede the development of CVD and DKD in youth-onset T2D. This proposal describes a pilot and feasibility trial ev
Systolic Blood Pressure
Baseline and 1 week post treatment · mmHg
| Men With Youth-onset T2D | 80 ± 12 mmHg |
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| Men With Youth-onset T2D | 85 ± 11 mmHg |
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Diastolic Blood Pressure
Baseline and 1 week post treatment · mmHg
| Men With Youth-onset T2D | 135 ± 13 mmHg |
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| Men With Youth-onset T2D | 132 ± 9 mmHg |
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Mean Arterial Pressure
Baseline and 1 week post treatment · mmHg
| Men With Youth-onset T2D | 98 ± 10 mmHg |
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| Men With Youth-onset T2D | 101 ± 10 mmHg |
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Open in BENITIONS
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