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High urate levels in the transition to gout

The development of gout in people with asymptomatic hyperuricemia: a 5-year prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000915156
Acronym
TIGER (Transitions In Gout Research) study
Enrollment
270
Registered
2019-07-01
Start date
2019-07-31
Completion date
2024-08-31
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine whether ultrasound evidence of urate crystal deposition is a necessary precondition for the development of gout and to understand the pathological mechanisms responsible for the transition from asymptomatic crystal deposition to gout. This five year prospective study, led from Auckland, New Zealand, will involve the recruitment of over 900 participants across multiple international sites. Eligible participants will attend a baseline study visit which will include recording of demographic information, a physical exam, assessment of clinical risk factors, and assessment of health related quality of life, activity limitations, illness perception and pain. Whole blood, serum and urine samples will be collected for biochemical and genetic testing. Bilateral radiographs of the feet will be obtained and an ultrasound assessment of the feet and knees will be performed to assess for crystal deposition, bone erosion and features of soft tissue inflammation. Participants will be followed up six-monthly to determine whether they have developed symptoms of new joint pain or swelling. Participants will attend a second visit after 5 years, or earlier if they develop gout, where these outcomes will be re-assessed.

Interventions

This is a prospective cohort study of people with asymptomatic hyperuricemia. Participants will attend a baseline study visit where clinical data will be collected, blood samples will be obtained, and an ultrasound scan performed. Participants will then be followed for 5 years to identify factors associated with the development of symptomatic gout. During the 5 year follow-up period participants will be contacted every 6 months to assess gout development. If participants develop gout during the

This is a prospective cohort study of people with asymptomatic hyperuricemia. Participants will attend a baseline study visit where clinical data will be collected, blood samples will be obtained, and an ultrasound scan performed. Participants will then be followed for 5 years to identify factors associated with the development of symptomatic gout. During the 5 year follow-up period participants will be contacted every 6 months to assess gout development. If participants develop gout during the 5 year follow-up period they will attend a second study visit, where the baseline assessments will be repeated. If participants do not develop gout, they will continue in the study and attend a final study visit at 5 years where the baseline assessments will be repeated.

Sponsors

The University of Auckland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Current serum urate level of greater than or equal to 8 mg/dl 2. No current or previous clinical symptoms of gout (including flares or clinically apparent tophi) 3. Able to provide informed consent, according to requirements of local IRB/ethics committee

Exclusion criteria

1. eGRF < 30 mL/min/1.73 m² or on renal replacement therapy 2. Serious illness with poor prognosis less than 5 years 3. Plans to shift out of area in the next 5 years 4. Previous synovial fluid analysis showing MSU crystals 5. The presence of subcutaneous tophi 6. Taking urate lowering therapy (e.g. allopurinol, probenecid, benzbromarone, febuxostat), canakinumab, or colchicine.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026