Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03899883 · ClinicalTrials.gov registry record · Phase 2
Uric Acid Lowering Trial in Youth Onset T2D
A Phase 2 study, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03899883 is a Phase 2 study that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 10 participants.
The verdict
NCT03899883, a Phase 2 study, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Pegloticase 8 MG/ML [Krystexxa]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03899883
The ClinicalTrials.gov registry entry for NCT03899883 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pegloticase 8 MG/ML [Krystexxa] is the first listed.
NCT03899883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03899883 about?
NCT03899883 is a clinical study titled "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 als...
What is the current status of trial NCT03899883?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2020-01-01. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03899883?
The interventions under investigation include: Pegloticase 8 MG/ML [Krystexxa] (DRUG).
Who is sponsoring clinical trial NCT03899883?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.