Uric Acid Lowering Trial in Youth Onset T2D (ULTRA-T2D)

June 30, 2026 updated by: University of Colorado, Denver

ULTRA-T2D Study: Uric Acid Lowering Trial in Youth Onset T2D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men
  • Ages 18-25
  • Youth-onset T2D (diagnosis <21 years)
  • serum uric acid ≥ 5 mg/dl

Exclusion Criteria:

  • Glucose-6-phosphate (G6P) deficiency
  • Allergies to seafood or iodine
  • MRI contraindications (severe claustrophobia, non-MRI compatible implantable devices, weight ≥ 450 lbs)
  • HbA1C ≥ 12%
  • Recent (1 month prior) diagnosis of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemia
  • Congestive heart failure
  • History of multiple and/or severe allergies or anaphylactic reactions
  • Uric acid lowering medications (ie: allopurinol, febuxostat)
  • Pegvisomant, pegvaliase, peginterferon alfa 2b, peginterferon alfa 2a, pegfilgrastim, pegaspargase, pegaptanib, pegademase and certolizumab pegol
  • Participation in another investigational study within 2 weeks prior to study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegloticase
Single administration of pegloticase (8 mg IV in 250 mL 0.9% normal saline)
Drug: Pegloticase 8 MG/ML [Krystexxa]
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: Baseline and 1 week post treatment
Systolic blood pressure measured by sphygmomanometer
Baseline and 1 week post treatment
Diastolic Blood Pressure
Time Frame: Baseline and 1 week post treatment
Diastolic blood pressure measured by sphygmomanometer
Baseline and 1 week post treatment
Mean Arterial Pressure
Time Frame: Baseline and 1 week post treatment
Mean arterial pressure measured by sphygmomanometer
Baseline and 1 week post treatment
Pulse Wave Velocity (PWV)
Time Frame: Baseline and 1 week post treatment
Measured by Aortic MRI renal MRI (4D Flow)
Baseline and 1 week post treatment
Wall Shear Stress (WSS)
Time Frame: Baseline and 1 week post treatment
Measured by Aortic MRI renal MRI (4D Flow)
Baseline and 1 week post treatment
Renal Blood Flow
Time Frame: Baseline and 1 week post treatment
Measured by 4D Flow renal MRI
Baseline and 1 week post treatment
Glomerular Filtration Rate
Time Frame: Baseline and 1 week post treatment
Measured by Iohexol Clearance in Plasma
Baseline and 1 week post treatment
Urine Albumin-creatinine Ratio
Time Frame: Baseline and 1 week post treatment
Measured by albumin and creatinine concentrations in urine
Baseline and 1 week post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Uric Acid (sUA)
Time Frame: Baseline and 1 week post treatment
Measured by baseline sUA compared to sUA one week later
Baseline and 1 week post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 13, 2023

Study Completion (Actual)

April 13, 2023

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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