Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease

NCT01350388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-10-03

Study results available
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Summary

Hyperuricemia is emerging as a risk factor for development of diabetes and metabolic syndrome. Recently, it was shown in in-vitro cell culture experiments that hyperuricemia induces redox-dependent signaling and oxidative stress in adipocytes. By targeting levels of uric acid with febuxostat it is hypothesized that the levels of oxidative stress in adipose tissue (obtained by fat biopsy) will decrease.

Primary aims of the study are to determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 Chronic Kidney Disease (CKD) and high serum uric acid levels

1. will affect adipose tissue concentrations of thiobarbituric acid reactive substance (TBARS), a marker of oxidative stress
2. will affect adipose tissue expression and concentrations of adiponectin; and
3. will affect urinary concentrations of transforming growth factor (TGF)- B1.

Conditions

Interventions

DRUG

Febuxostat

80 mg/day of febuxostat for 24 weeks

DRUG

Placebo

1 placebo tablet per day for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Srinivasan Beddhu, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01350388 on ClinicalTrials.gov