BENITIONSClinical Trial Intelligence

Uric Acid Lowering Trial in Youth Onset T2D

第2相 完了 NCT03899883

対象疾患Diabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2
第2相
スポンサーUniversity of Colorado, Denver
ステータス完了
参加者数11 名
介入(薬剤)Pegloticase 8 MG/ML [Krystexxa]
開始日2020年1月1日
完了日2023年4月13日
結果公開日2026年7月28日

概要

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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