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Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naim Maalouf, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01654276
First received: June 28, 2012
Last updated: November 18, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Gout Drug: Febuxostat Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Naim Maalouf, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: May 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Febuxostat
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.
Drug: Febuxostat
One 40 mg tablet once a day for 6 months
Other Name: Uloric

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654276

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8885
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Naim M Maalouf, MD UT Southwestern Medical Center
  More Information

Responsible Party: Naim Maalouf, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01654276     History of Changes
Other Study ID Numbers: MSA-FEB-137
Study First Received: June 28, 2012
Results First Received: April 2, 2015
Last Updated: November 18, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Metabolic Syndrome X
Hyperuricemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Febuxostat
Gout Suppressants
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 21, 2017