N/A
Completed N=80
Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01350388 ↗Enrolled (actual)
80
Serious AEs
5.0%
Results posted
Oct 2016
Primary outcomePrimary: Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks — 34.0; 44.6 percent difference in geometric mean — p=0.84
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks |
34.0; 44.6 | 0.84 |
| PRIMARY Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks |
2.3; -4.1 | 0.73 |
| PRIMARY Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks |
29.8; 10.0 | 0.23 |
| SECONDARY Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks |
-9.9; -7.4 | 0.88 |
| SECONDARY Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks |
-24.0; -9.5 | 0.13 |
| SECONDARY Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks |
12.2; -7.2 | 0.35 |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- BMI > 25 kg/m2
- type 2 diabetes
- serum uric acid ≥ 5.5 mg/dl in men and ≥ 4.6 mg/dl in women
- eGFR 30-60 mL/min/1.73m2
Exclusion Criteria
- History of gout
- concurrent use of azathioprine, mercaptopurine, theophylline, allopurinol, thiazolidinediones or warfarin
- concurrent use of metformin
- current antibiotic therapy
- pregnant women
- prisoners
Data sourced from ClinicalTrials.gov (NCT01350388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.