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Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome

Primary Purpose

Gout

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Febuxostat
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Febuxostat

Arm Description

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.

Outcomes

Primary Outcome Measures

BMI
Serum Uric Acid
Serum Creatinine
Ambulatory Systolic Blood Pressure
Systolic BP by ambulatory blood pressure monitor.
Ambulatory Diastolic Blood Pressure
Diastolic BP by ambulatory blood pressure monitor.
Serum Glucose
Serum Insulin
Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)
Seum Total Cholesterol
Serum HDL-cholesterol
Serum Triglycerides
Urine Uric Acid
Urine Creatinine
Fractional Excretion UA
Urine pH

Secondary Outcome Measures

Full Information

First Posted
June 28, 2012
Last Updated
February 16, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01654276
Brief Title
Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
Official Title
Effects of Pharmacological Reversal of Hyperuricemia on Features of the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Febuxostat
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
Uloric
Intervention Description
One 40 mg tablet once a day for 6 months
Primary Outcome Measure Information:
Title
BMI
Time Frame
6 months
Title
Serum Uric Acid
Time Frame
6 months
Title
Serum Creatinine
Time Frame
6 months
Title
Ambulatory Systolic Blood Pressure
Description
Systolic BP by ambulatory blood pressure monitor.
Time Frame
6 months
Title
Ambulatory Diastolic Blood Pressure
Description
Diastolic BP by ambulatory blood pressure monitor.
Time Frame
6 months
Title
Serum Glucose
Time Frame
6 months
Title
Serum Insulin
Time Frame
6 months
Title
Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)
Time Frame
6 months
Title
Seum Total Cholesterol
Time Frame
6 months
Title
Serum HDL-cholesterol
Time Frame
6 months
Title
Serum Triglycerides
Time Frame
6 months
Title
Urine Uric Acid
Time Frame
6 months
Title
Urine Creatinine
Time Frame
6 months
Title
Fractional Excretion UA
Time Frame
6 months
Title
Urine pH
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naim M Maalouf, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8885
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29622755
Citation
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.
Results Reference
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Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome

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