Trial Outcomes & Findings for Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome (NCT NCT01654276)

NCT ID: NCT01654276

Last Updated: 2023-03-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-03-14

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	24
Overall Study Visit 2 (2 Months)	19
Overall Study Visit 3 (4 Months)	18
Overall Study Visit 4 (6months)	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	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
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome

Baseline characteristics by cohort

Measure	Gout and Hyperuricemia n=24 Participants 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
Age, Continuous	56 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
BMI	33.4 kg/m^2 Standard Deviation 5.9

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Serum Uric Acid	4.4 mg/dl Standard Deviation 1.1

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Serum Creatinine	0.98 mg/dl Standard Deviation 0.22

PRIMARY outcome

Timeframe: 6 months

Systolic BP by ambulatory blood pressure monitor.

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Ambulatory Systolic Blood Pressure	126 mmHg Standard Deviation 14

PRIMARY outcome

Timeframe: 6 months

Diastolic BP by ambulatory blood pressure monitor.

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Ambulatory Diastolic Blood Pressure	75 mmHg Standard Deviation 9

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Serum Glucose	107 mg/dl Standard Deviation 30

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Serum Insulin	14 mU/L Standard Deviation 6.1

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)	1.86 Homeostatic model assessment for Insulin Standard Deviation .83

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Seum Total Cholesterol	196 mg/dl Standard Deviation 46

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Serum HDL-cholesterol	49 mg/dl Standard Deviation 16

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Serum Triglycerides	175 mg/dl Standard Deviation 107

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Urine Uric Acid	208 mg/dl Standard Deviation 137

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Urine Creatinine	1332 mg/dl Standard Deviation 669

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Fractional Excretion UA	0.04 % of serum uric acid excreted in urine Standard Deviation 0.02

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Gout and Hyperuricemia n=18 Participants 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
Urine pH	5.58 pH Standard Deviation 0.43

Adverse Events

Gout and Hyperuricemia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gout and Hyperuricemia n=24 participants at risk 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
Hepatobiliary disorders Abnormal Liver Function Test	0.00% 0/24 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Naim Maalouf. MD

University of Texas Southwestern Medical Center

Phone: 214-648-2954

Email: naim.maalouf@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place