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Completed

NCT Number: NCT05332795

The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

Objective:

To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.

Methods:

A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.

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Key information

Conditions

Gouty Arthritis Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dalia Salah Saif

Menoufia Governorate, MD, 123455, Egypt

About this study

Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways.

Objective:

To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.

Methods:

A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gouty patients who fulfilled the American College of Rheumatology clinical criteria.
  • gouty patients with active inflammatory arthritis.

Exclusion criteria

  • Patients with any type of inflammatory arthritis.
  • Patients with systemic disease as diabetes, hypertension,
  • Patients with hyperlipidemia, coronary artery disease,
  • Patients with renal or hepatic insults,
  • pregnant and lactating females

Treatment and study plan

metformin

Drug

gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.

Placebo

Drug

gouty patients, will receive placebo tablets once daily for about 3 months.

Primary outcomes

  1. Serological remission criteria

    Time frame: at 3 months post intervention.

    by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.

  2. Articular remission criteria

    Time frame: at 3 months post intervention.

    by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..

  3. Clinical remission criteria

    Time frame: at 3 months post intervention.

    by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale

Secondary outcomes

  1. Gout Impact Scale (GIS)

    Time frame: at 3 months post intervention.

    by measuring GIS score, as higher scores in the GIS (range 0-100) imply a greater restriction of activity and a greater impact of gout and vice versa.

Other outcomes

  1. Health-related quality of life HRQOL

    Time frame: at 3 months post intervention.

    Health-related quality of life HRQOL was assessed using the SF-36 subscale of physical functioning (PF-10), as Lower PF-10 scores (range 0-100) imply more functional limitations, and vice versa.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Acronym: Mets in gout

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 18, 2022
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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