Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Pharmacological Reversal of Hyperuricemia on Features of the Metabolic Syndrome|
- Insulin sensitivity measured by HOMA (HOmeostasis Model Assessment) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Ambulatory Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Fasting serum glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Fasting serum triglycerides [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Fasting serum HDL-cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Fasting urine pH [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2019 (Final data collection date for primary outcome measure)|
Experimental: Gout and hyperuricemia
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654276
|Contact: Naim M Maalouf, MDfirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-8885|
|Principal Investigator:||Naim M Maalouf, MD||UT Southwestern Medical Center|