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
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
-
1 placebo tablet per day for 24 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
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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