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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gout
Intervention Drug: Febuxostat
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Period Title: Overall Study
Started 24
Visit 2 (2 Months) 19
Visit 3 (4 Months) 18
Visit 4 (6months) 18
Completed 18
Not Completed 6
Reason Not Completed
Lack of Efficacy             1
Lost to Follow-up             4
Withdrawal by Subject             1
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
56  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
6
  25.0%
Male
18
  75.0%
1.Primary Outcome
Title BMI
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: kg/m^2
33.4  (5.9)
2.Primary Outcome
Title Serum Uric Acid
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
4.4  (1.1)
3.Primary Outcome
Title Serum Creatinine
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.98  (0.22)
4.Primary Outcome
Title Ambulatory Systolic Blood Pressure
Hide Description Systolic BP by ambulatory blood pressure monitor.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mmHg
126  (14)
5.Primary Outcome
Title Ambulatory Diastolic Blood Pressure
Hide Description Diastolic BP by ambulatory blood pressure monitor.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mmHg
75  (9)
6.Primary Outcome
Title Serum Glucose
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
107  (30)
7.Primary Outcome
Title Serum Insulin
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mU/L
14  (6.1)
8.Primary Outcome
Title Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: Homeostatic model assessment for Insulin
1.86  (.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gout and Hyperuricemia
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Primary Outcome
Title Seum Total Cholesterol
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
196  (46)
10.Primary Outcome
Title Serum HDL-cholesterol
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
49  (16)
11.Primary Outcome
Title Serum Triglycerides
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
175  (107)
12.Primary Outcome
Title Urine Uric Acid
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
208  (137)
13.Primary Outcome
Title Urine Creatinine
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mg/dl
1332  (669)
14.Primary Outcome
Title Fractional Excretion UA
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: % of serum uric acid excreted in urine
0.04  (0.02)
15.Primary Outcome
Title Urine pH
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: pH
5.58  (0.43)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gout and Hyperuricemia
Hide Arm/Group 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.

Febuxostat: One 40 mg tablet once a day for 6 months

All-Cause Mortality
Gout and Hyperuricemia
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gout and Hyperuricemia
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Hepatobiliary disorders   
Abnormal Liver Function Test  1 [1]  0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Blood
[1]
Serum Liver function tests at months 2, 4 and 6.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gout and Hyperuricemia
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Naim Maalouf. MD
Organization: University of Texas Southwestern Medical Center
Phone: 214-648-2954
Responsible Party: Naim Maalouf, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01654276     History of Changes
Other Study ID Numbers: MSA-FEB-137
First Submitted: June 28, 2012
First Posted: July 31, 2012
Results First Submitted: April 2, 2015
Results First Posted: January 13, 2017
Last Update Posted: June 18, 2018