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Completed

NCT Number: NCT01654276

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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390-8885, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Febuxostat

Drug

One 40 mg tablet once a day for 6 months

Other names: Uloric

Primary outcomes

  1. BMI

    Time frame: 6 months

  2. Serum Uric Acid

    Time frame: 6 months

  3. Serum Creatinine

    Time frame: 6 months

  4. Ambulatory Systolic Blood Pressure

    Time frame: 6 months

    Systolic BP by ambulatory blood pressure monitor.

  5. Ambulatory Diastolic Blood Pressure

    Time frame: 6 months

    Diastolic BP by ambulatory blood pressure monitor.

  6. Serum Glucose

    Time frame: 6 months

  7. Serum Insulin

    Time frame: 6 months

  8. Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)

    Time frame: 6 months

  9. Seum Total Cholesterol

    Time frame: 6 months

  10. Serum HDL-cholesterol

    Time frame: 6 months

  11. Serum Triglycerides

    Time frame: 6 months

  12. Urine Uric Acid

    Time frame: 6 months

  13. Urine Creatinine

    Time frame: 6 months

  14. Fractional Excretion UA

    Time frame: 6 months

  15. Urine pH

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Effects of Pharmacological Reversal of Hyperuricemia on Features of the Metabolic Syndrome

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2012
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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