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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350388
• Other study ID #: IRB_00044016
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: January 6, 2014
• Start date: May 2011

Study information

• Verified date: January 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 we hypothesize that the levels of oxidative stress in adipose tissue (obtained by fat biopsy) will decrease.

Primary aims of the study is to determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 CKD and high serum uric acid levels

1. decreases adipose tissue concentrations of thiobarbituric acid reactive substance (TBARS), a marker of oxidative stress

2. increases adipose tissue expression and concentrations of adiponectin and

3. decreases urinary concentrations of transforming growth factor (TGF)- B1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Febuxostat
80 mg/day of febuxostat for 6 months
• Sugar pill
1 pill a day for 6 months

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Febuxostat on TBARS, adiponectin and transforming growth factor	To determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 CKD and high serum uric acid levels; decreases adipose tissue concentrations of thiobarbituric acid reactive substance (TBARS), a marker of oxidative stress; increases adipose tissue expression and concentrations of adiponectin and; decreases urinary concentrations of transforming growth factor (TGF)- B1.	6 months	No
Secondary	Effects of Febuxostat on plasma adiponectin, TNF-alpha, IL-6, hsCRP and albumin	To determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 CKD and high serum uric acid levels; increases plasma concentrations of adiponectin; decreases adipose tissue expression and concentrations of TNF-alpha and IL-6 and; decreases plasma concentrations of TNF-alpha, IL-6 and high sensitivity C-reactive protein (hsCRP) and; decreases urinary concentrations of albumin	6 months	No