Uric Acid Lowering Trial in Youth-Onset Type 2 Diabetes

This study is looking at how a medicine called Pegloticase (Krystexxa) affects blood pressure in young men with type 2 diabetes (T2D) that started in their youth. We know that high uric acid levels are common in young men with youth-onset T2D and can be linked to high blood pressure and kidney problems. This study wants to see if lowering uric acid with a single dose of Pegloticase can improve blood pressure. To join, you must be a man between 18 and 25 years old, have youth-onset T2D, and have high uric acid levels (serum uric acid ≥ 5 mg/dl). The study will measure your blood pressure at the start and one week after treatment to see if it changes. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 11 participants.
What's involved
You would receive a single infusion of Pegloticase over two hours in an outpatient clinic and be monitored afterward. Your blood pressure will be measured at the start and one week after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one week after treatment, with blood pressure measurements taken at baseline and one week post-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03899883

Uric Acid Lowering Trial in Youth Onset T2D

Completed
PHASE2Ages 18–25InterventionalTreatment
University of Colorado, Denver
~11 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Pegloticase 8 MG/ML [Krystexxa]

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systolic Blood Pressure
Measured over Baseline and 1 week post treatment
+7 more outcomes measured
Diabetic Kidney Disease
Hyperuricemia
Diabetes
Diabetes Mellitus, Type 2
Type2 Diabetes
Type 2 Diabetes Mellitus
Diabetic Nephropathies
Diabetes Complications
1 sites across 1 states
Colorado1

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Systolic Blood PressureBaseline and 1 week post treatment

    Systolic blood pressure measured by sphygmomanometer

  • Diastolic Blood PressureBaseline and 1 week post treatment

    Diastolic blood pressure measured by sphygmomanometer

  • Mean Arterial PressureBaseline and 1 week post treatment

    Mean arterial pressure measured by sphygmomanometer

  • Pulse Wave Velocity (PWV)Baseline and 1 week post treatment

    Measured by Aortic MRI renal MRI (4D Flow)

  • Wall Shear Stress (WSS)Baseline and 1 week post treatment

    Measured by Aortic MRI renal MRI (4D Flow)

  • Renal Blood FlowBaseline and 1 week post treatment

    Measured by 4D Flow renal MRI

  • Glomerular Filtration RateBaseline and 1 week post treatment

    Measured by Iohexol Clearance in Plasma

  • Urine Albumin-creatinine RatioBaseline and 1 week post treatment

    Measured by albumin and creatinine concentrations in urine