NCT01931527

Brief Summary

The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 15, 2015

Completed
Last Updated

August 14, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

August 23, 2013

Results QC Date

April 28, 2015

Last Update Submit

July 16, 2018

Conditions

ObesityMetabolic SyndromeHyperuricemia

Keywords

ObesityMetabolic syndromeHyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Percent Increase in Insulin-stimulated Glucose Uptake

    Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure percent increase in insulin-stimulated glucose uptake in obese subjects with high uric acid before and after uric acid reduction.

    12 hours after reducing uric acid

Secondary Outcomes (7)

  • The Effect of Reducing Uric Acid on Oxidative Status

    12 hours after reducing uric acid

  • Baseline Carbonylated Protein Ratio

    Before reducing uric acid

  • AFTER Rasburicase Carbonylated Protein Ratio

    12 hours after reducing uric acid

  • Baseline Plasma TRAP

    Before reducing uric acid

  • AFTER Rasburicase Plasma TRAP

    12 hours after reducing uric acid

  • +2 more secondary outcomes

Study Arms (2)

Obese subjects with normal uric acid

NO INTERVENTION

Subjects with a body mass index = or \> 30 kg/m² with normal uric acid (= or \< 5 mg/dL)

Obese subjects with high uric acid

EXPERIMENTAL

Subjects with a body mass index = or \> 30 kg/m² with high uric acid (\>6 mg/dL) Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min

Drug: Rasburicase

Interventions

RasburicaseDRUG

one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min

Also known as: Elitek
Obese subjects with high uric acid

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obese (BMI 30-45 kg/m²);
  • serum UA concentration either ≥5 mg/dL or ≤4.0 mg/dL (297 µmol/L)\],

You may not qualify if:

  • renal dysfunction (serum creatinine \>1.5 mg/dL);
  • pregnancy or lactating;
  • take urate-lowering agents, thiazide diuretics, prednisone or medications containing aspirin or other salicylates;
  • history of xanthinuria, type 2 diabetes or other significant organ system dysfunction;
  • have G6PD deficiency;
  • use hormone-replacement or oral-contraceptive therapy;
  • smoke tobacco;
  • anemic (Hb \<10 g/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

ObesityMetabolic SyndromeHyperuricemia

Interventions

rasburicase

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Results Point of Contact

Title
Elisa Fabbrini, MD, PhD
Organization
Washington University School of Medicine
efabbrini@dom.wustl.edu
314-362-8156

Study Officials

  • Samuel Klein, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 29, 2013

Study Start

July 1, 2006

Primary Completion

June 1, 2008

Study Completion

November 1, 2012

Last Updated

August 14, 2018

Results First Posted

May 15, 2015

Record last verified: 2018-07

Locations

US(1)