NCT01654276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 13, 2017

Completed
Last Updated

March 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

June 28, 2012

Results QC Date

April 2, 2015

Last Update Submit

February 16, 2023

Conditions

Gout

Outcome Measures

Primary Outcomes (15)

  • 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

    6 months

  • Urine Creatinine

    6 months

  • Fractional Excretion UA

    6 months

  • Urine pH

    6 months

Study Arms (1)

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.

Drug: Febuxostat

Interventions

FebuxostatDRUG

One 40 mg tablet once a day for 6 months

Also known as: Uloric
Febuxostat

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 21 years
  • Gout
  • Hyperuricemia (serum uric acid \> 7.0 mg/dl in men and \>6.0 mg/dl in women).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-8885, United States

Location

Related Publications (1)

  • 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.

    PMID: 29622755BACKGROUND

MeSH Terms

Conditions

Gout

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Naim Maalouf. MD
Organization
University of Texas Southwestern Medical Center
naim.maalouf@utsouthwestern.edu
214-648-2954

Study Officials

  • Naim M Maalouf, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 31, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 14, 2023

Results First Posted

January 13, 2017

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)