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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febuxostat | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | One 40 mg tablet once a day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI | 6 months | |
| Serum Uric Acid | 6 months | |
| Serum Creatinine | 6 months | |
| Ambulatory Systolic Blood Pressure | Systolic BP by ambulatory blood pressure monitor. | 6 months |
| Ambulatory Diastolic Blood Pressure | Diastolic BP by ambulatory blood pressure monitor. | 6 months |
| Serum Glucose | 6 months | |
| Serum Insulin | 6 months | |
| Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment) | 6 months | |
| Seum Total Cholesterol | 6 months | |
| Serum HDL-cholesterol | 6 months | |
| Serum Triglycerides | 6 months | |
| Urine Uric Acid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naim M Maalouf, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390-8885 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29622755 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Febuxostat: One 40 mg tablet once a day for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Febuxostat: One 40 mg tablet once a day for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BMI | Posted | Mean | Standard Deviation | kg/m^2 | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Febuxostat: One 40 mg tablet once a day for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Liver Function Test | Hepatobiliary disorders | Blood | Systematic Assessment | Serum Liver function tests at months 2, 4 and 6. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naim Maalouf. MD | University of Texas Southwestern Medical Center | 214-648-2954 | naim.maalouf@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 6 months |
| Urine Creatinine | 6 months |
| Fractional Excretion UA | 6 months |
| Urine pH | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Serum Uric Acid | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
| Primary | Serum Creatinine | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
| Primary | Ambulatory Systolic Blood Pressure | Systolic BP by ambulatory blood pressure monitor. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Primary | Ambulatory Diastolic Blood Pressure | Diastolic BP by ambulatory blood pressure monitor. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Primary | Serum Glucose | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
| Primary | Serum Insulin | Posted | Mean | Standard Deviation | mU/L | 6 months |
|
|
|
| Primary | Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment) | Posted | Mean | Standard Deviation | Homeostatic model assessment for Insulin | 6 months |
|
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|
|
| Primary | Seum Total Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
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| Primary | Serum HDL-cholesterol | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
| Primary | Serum Triglycerides | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
| Primary | Urine Uric Acid | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
| Primary | Urine Creatinine | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
| Primary | Fractional Excretion UA | Posted | Mean | Standard Deviation | % of serum uric acid excreted in urine | 6 months |
|
|
|
| Primary | Urine pH | Posted | Mean | Standard Deviation | pH | 6 months |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
|
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |