The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients. (Mets in gout)

Menoufia University

Status: Completed

Conditions: Gouty Arthritis

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05332795

1478

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

group 1: gouty patients on metformin.

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

gouty patients on placebo.

Placebo Comparator group

Description:

placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.

Treatment:

Drug: Placebo