Uric Acid Lowering Trial in Youth Onset T2D

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03899883
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Pegloticase 8 MG/ML [Krystexxa] — DRUG
    One time dosing of pegloticase will be administered. Participants will receive an infusion of pegloticase over two hours in the outpatient clinical and translational research center (CTRC) at Children's Hospital Colorado, and will be monitored after infusion.

Study Details

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 evaluating the effect of UA lowering by pegloticase on markers of CVD and DKD in ten (n=10) youth aged 18-25 with youth-onset T2D (diagnosed \<21 years of age) over 7 days. The overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering UA.

Key Dates

Start date
Jan 1, 2020
Status verified
Feb 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pegloticase
    Single administration of pegloticase (8 mg IV in 250 mL 0.9% normal saline)

Primary Outcome Measure

Cardiovascular Markers [ Time Frame: 5 min ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Amy Rydin, MD
[email protected]
720-777-2560
Carissa Vinovskis, MS
[email protected]
720-777-2660
Amy Rydin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital Colorado· Aurora, CO

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