Phase 4
Completed N=24
Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
Source: ClinicalTrials.gov NCT01654276 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: BMI — 33.4 kg/m^2
◆ Published Evidence
Emerging
2citations · ~0 / year
Effects of pharmacological reversal of hyperuricemia on features of the metabolic syndrome in patients with gouty arthritis.
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.
Linked Publications
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Effects of pharmacological reversal of hyperuricemia on features of the metabolic syndrome in patients with gouty arthritis.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01654276) and the linked publication. 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.