Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT01654276|
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : January 13, 2017
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: Febuxostat||Phase 4|
The metabolic syndrome (MS) is characterized by a constellation of metabolic features including dyslipidemia, hyperglycemia, hypertension, obesity, and insulin resistance. This cluster of features is strongly associated with type 2 diabetes, atherosclerotic cardiovascular disease, and increased cardiovascular and all-cause mortality. Hyperuricemia (elevated serum uric acid) is associated with insulin resistance and features of the MS in cross-sectional epidemiological studies. However, it remains unclear whether this association is causal or simply coincidental. If hyperuricemia CAUSES insulin resistance, then lowering serum uric acid by pharmacological means may result in improved insulin sensitivity and reversal of features of the metabolic syndrome. In some recent small studies, lowering serum uric acid with allopurinol was associated with improvement in some of the features and/or complications of the MS: Allopurinol use resulted in reduction in blood pressure in adolescents and improvement in exercise capacity in patients with chronic stable angina. A low urine pH is strongly associated with insulin resistance, and individual features of the metabolic syndrome. Similarly, a low fractional excretion of uric acid is also associated with metabolic syndrome feature. We therefore would like to examine the effect on febuxostat on these two parameters which have been linked with the metabolic syndrome.
The goal of this study is to evaluate whether pharmacological lowering of serum uric acid with the medication febuxostat is associated with improvement in the degree of insulin resistance and various features of the metabolic syndrome.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Pharmacological Reversal of Hyperuricemia on Features of the Metabolic Syndrome|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
One 40 mg tablet once a day for 6 months
Other Name: Uloric
- BMI [ Time Frame: 6 months ]
- Serum Uric Acid [ Time Frame: 6 months ]
- Serum Creatinine [ Time Frame: 6 months ]
- Ambulatory Systolic Blood Pressure [ Time Frame: 6 months ]Systolic BP by ambulatory blood pressure monitor.
- Ambulatory Diastolic Blood Pressure [ Time Frame: 6 months ]Diastolic BP by ambulatory blood pressure monitor.
- Serum Glucose [ Time Frame: 6 months ]
- Serum Insulin [ Time Frame: 6 months ]
- Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment) [ Time Frame: 6 months ]
- Seum Total Cholesterol [ Time Frame: 6 months ]
- Serum HDL-cholesterol [ Time Frame: 6 months ]
- Serum Triglycerides [ Time Frame: 6 months ]
- Urine Uric Acid [ Time Frame: 6 months ]
- Urine Creatinine [ Time Frame: 6 months ]
- Fractional Excretion UA [ Time Frame: 6 months ]
- Urine pH [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654276
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390-8885|
|Principal Investigator:||Naim M Maalouf, MD||UT Southwestern Medical Center|