BENITIONSClinical Trial Intelligence

Uric Acid Lowering Trial in Youth Onset T2D

2期 已完成 NCT03899883

适应症Diabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2
分期2期
申办方University of Colorado, Denver
状态已完成
受试者人数11 人
干预(药物)Pegloticase 8 MG/ML [Krystexxa]
开始日期2020年1月1日
完成日期2023年4月13日
结果公布日2026年7月28日

摘要

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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。