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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gouty Arthritis

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1: gouty patients on metformin.<br>metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. | Drug: Metformin<br>* gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.<br>|
| Placebo Comparator: gouty patients on placebo.<br>placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months. | Drug: Placebo<br>* gouty patients, will receive placebo tablets once daily for about 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological remission criteria | by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL. | at 6 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.. | at 6 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 | at 6 months post intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 6 months post intervention. |