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Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01654276
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : January 13, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Naim Maalouf, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE June 28, 2012
First Posted Date  ICMJE July 31, 2012
Results First Submitted Date  ICMJE April 2, 2015
Results First Posted Date  ICMJE January 13, 2017
Last Update Posted Date June 18, 2018
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment) [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01654276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
  • Ambulatory Blood Pressure [ Time Frame: 6 months ]
  • Fasting serum glucose [ Time Frame: 6 months ]
  • Fasting serum triglycerides [ Time Frame: 6 months ]
  • Fasting serum HDL-cholesterol [ Time Frame: 6 months ]
  • Fasting urine pH [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
Official Title  ICMJE Effects of Pharmacological Reversal of Hyperuricemia on Features of the Metabolic Syndrome
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE Drug: Febuxostat
One 40 mg tablet once a day for 6 months
Other Name: Uloric
Study Arms  ICMJE 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.
Intervention: Drug: Febuxostat
Publications * Marin M, Maalouf NM. Effects of pharmacological reversal of hyperuricemia on features of the metabolic syndrome in patients with gouty arthritis. J Investig Med. 2018 Oct;66(7):1031-1036. doi: 10.1136/jim-2018-000728. Epub 2018 Apr 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2016)
24
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2012)
30
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01654276
Other Study ID Numbers  ICMJE MSA-FEB-137
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Naim Maalouf, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Naim M Maalouf, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP