RECRUITING

Uric Acid Lowering Trial in Youth Onset T2D

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-01-01
Study Completion:2023-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03899883

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.

Ages Eligible for Study:18 Years to 25 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men
  2. * Ages 18-25
  3. * Youth-onset T2D (diagnosis \<21 years)
  4. * serum uric acid ≥ 5 mg/dl
  1. * Glucose-6-phosphate (G6P) deficiency
  2. * Allergies to seafood or iodine
  3. * MRI contraindications (severe claustrophobia, non-MRI compatible implantable devices, weight ≥ 450 lbs)
  4. * HbA1C ≥ 12%
  5. * Recent (1 month prior) diagnosis of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemia
  6. * Congestive heart failure
  7. * History of multiple and/or severe allergies or anaphylactic reactions
  8. * Uric acid lowering medications (ie: allopurinol, febuxostat)
  9. * Pegvisomant, pegvaliase, peginterferon alfa 2b, peginterferon alfa 2a, pegfilgrastim, pegaspargase, pegaptanib, pegademase and certolizumab pegol
  10. * Participation in another investigational study within 2 weeks prior to study

Contacts and Locations

Study Contact

Amy Rydin, MD
CONTACT
720-777-2560
amy.rydin@childrenscolorado.org
Carissa Vinovskis, MS
CONTACT
720-777-2660
carissa.vinovskis@childrenscolorado.org

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2020-01-01
Study Completion Date2023-06-30

Study Record Updates

Study Start Date2020-01-01
Study Completion Date2023-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Kidney Disease
  • Hyperuricemia
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Type2 Diabetes
  • Type 2 Diabetes Mellitus
  • Diabetic Nephropathies
  • Diabetes Complications