Effects of Allopurinol on Inflammation and Ultrasonographic Changes in People With Elevated Uric Acid But no Symptoms

Summary

Hyperuricemia is a metabolic alteration defined as the presence of serum urate levels higher than 7 mg/dL. This has proven to be the maximum limit of solubility of urate in serum, any higher concentration leads to precipitation and eventually to the formation of monosodium urate (MSU) crystals. The accumulation of said crystals can manifest as gouty arthritis, uric acid nephropathy, urolithiasis or chronic tophaceous gout.

A strong relation between hyperuricemia and other chronic degenerative diseases, including diabetes mellitus, systemic arterial hypertension, obesity and metabolic syndrome, has been consistently proven.

Hypouricemic pharmacological agents have shown a decrease in cardiovascular complications and death in patients with gout.

A series of studies conducted on individuals with asymptomatic hyperuricemia using musculoskeletal ultrasound (MSUS) have shown the presence of morphostructural changes suggestive of MSU crystal deposits, combined with an elevation in a series of inflammation markers to a degree similar to those found in patients with chronic gout.

Even though, there is evidence of morphostructural damage in individuals with asymptomatic hyperuricemia, there are no clinical, laboratorial or imaging parameters that indicate when hypouricemic treatment should be started.

This clinical trial is proposed as a proof of concept which is looking to evaluate if treatment with allopurinol induces changes in levels of inflammatory markers in individuals with asymptomatic hyperuricemia and morphostructural changes suggestive of MSU crystal deposits. this proof of concept is not looking to measure the efficiency, effectiveness or security of the treatment.

Our Hypothesis is that Individuals with asymptomatic hyperuricemia and morphostructural changes evidenced by MSUS (double contour sing, tophi, aggregates) will show a decent in inflammatory markers and their morphostructural changes will diminish or revert after treatment with allopurinol.

Conditions

• Musculoskeletal Degeneration
• Inflammation
• Hyperuricemia

Interventions

DRUG

Allopurinol Pill

Individuals who meet the inclusion criteria and also have morphostructural changes suggestive of MSU crystal deposits in their MSUS will start treatment with allopurinol at a dosage of 150 mg to be taken daily, orally for a month and then to be increased to 300 mg. The rest of the individuals' medication is not to be altered. If a participant presents hypersensitivity to allopurinol, they are to stop the medication and will be excluded from the investigation. Three months after starting treatment, the participants will have a physical exam, confirm the continuation of the treatment (adjust dosage if needed) and take a blood sample for laboratory tests. Six months after treatment is started, the participants will be reevaluated by MSUS and have another blood sample taken, Once the study is finished, continuing or ending treatment with allopurinol will be decided by the medical judgment of the physician of each participant.

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion

  collaborator OTHER_GOV

• Instituto Nacional de Cardiologia Ignacio Chavez

  lead OTHER

Principal Investigators

• Luis M Amezcua-Guerra, MD · Instituto Nacional de Cardiologia Ignacio Chavez

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-30

Primary Completion

2020-07-30

Completion

2021-02-28

Countries

• Mexico

Study Locations