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

Menoufia University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Gouty Arthritis

Interventions

MetforminDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Dalia Salah Saif

Menoufia Governorate, MD, Egypt

Outcomes

Primary Outcomes

Serological remission criteria

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

Time frame: at 3 months post intervention.

Articular remission criteria

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

Time frame: at 3 months post intervention.

Clinical remission criteria

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

Time frame: at 3 months post intervention.

Secondary Outcomes

Gout Impact Scale (GIS)

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.

Time frame: at 3 months post intervention.

Data from ClinicalTrials.gov

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