BENITIONSClinical Trial Intelligence

Uric Acid Lowering Trial in Youth Onset T2D

Фаза 2 Завершено NCT03899883

ЗаболеваниеDiabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2
ФазаФаза 2
СпонсорUniversity of Colorado, Denver
СтатусЗавершено
Участники11 участн.
ВмешательствоPegloticase 8 MG/ML [Krystexxa]
Дата начала1.01.2020
Дата завершения13.04.2023
Публикация результатов28.07.2026

Кратко

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 T2D80 ± 12 mmHg
Men With Youth-onset T2D85 ± 11 mmHg

Diastolic Blood Pressure

Baseline and 1 week post treatment · mmHg

Men With Youth-onset T2D135 ± 13 mmHg
Men With Youth-onset T2D132 ± 9 mmHg

Mean Arterial Pressure

Baseline and 1 week post treatment · mmHg

Men With Youth-onset T2D98 ± 10 mmHg
Men With Youth-onset T2D101 ± 10 mmHg

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