Phase 4 N=24 Treatment

Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome

Gout

Bottom Line

View on ClinicalTrials.gov: NCT01654276 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: BMI — 33.4 kg/m^2

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Febuxostat (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY BMI	33.4	—
PRIMARY Serum Uric Acid	4.4	—
PRIMARY Serum Creatinine	0.98	—
PRIMARY Ambulatory Systolic Blood Pressure	126	—
PRIMARY Ambulatory Diastolic Blood Pressure	75	—
PRIMARY Serum Glucose	107	—
PRIMARY Serum Insulin	14	—
PRIMARY Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)	1.86	0.66
PRIMARY Seum Total Cholesterol	196	—
PRIMARY Serum HDL-cholesterol	49	—
PRIMARY Serum Triglycerides	175	—
PRIMARY Urine Uric Acid	208	—
PRIMARY Urine Creatinine	1332	—
PRIMARY Fractional Excretion UA	0.04	—
PRIMARY Urine pH	5.58	—

Summary

This study is being done to evaluate whether the medication, febuxostat, can improve the degree of insulin resistance and other features of the metabolic syndrome (high blood pressure, elevated insulin levels, excess body fat around the waist, and/or high cholesterol) by lowering uric acid levels in the blood.

Eligibility Criteria

Inclusion Criteria

Age > 21 years
Gout
Hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women).

Exclusion Criteria

Current treatment with insulin, azathioprine, mercaptopurine, or theophylline.
Treatment with febuxostat, allopurinol or other uricosuric agents (including losartan, probenecid) within the past year
Uncontrolled hypertension (clinic systolic blood pressure > 160 mmHg or diastolic blood pressure > 90 mmHg within the past 6 months)
Uncontrolled diabetes mellitus (HbA1c > 7%)
estimated GFR < 60 ml/min by MDRD
Elevated liver function tests (AST or ALT greater than 3 times the upper limit of normal)
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01654276). 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.