The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
NCT ID: NCT05332795
Last Updated: 2024-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-06-28
2024-02-20
Brief Summary
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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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Detailed Description
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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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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group 1: gouty patients on metformin.
metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months.
Metformin
gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.
gouty patients on placebo.
placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.
Placebo
gouty patients, will receive placebo tablets once daily for about 3 months.
Interventions
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Metformin
gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.
Placebo
gouty patients, will receive placebo tablets once daily for about 3 months.
Eligibility Criteria
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Inclusion Criteria
* gouty patients with active inflammatory arthritis.
Exclusion Criteria
* Patients with systemic disease as diabetes, hypertension,
* Patients with hyperlipidemia, coronary artery disease,
* Patients with renal or hepatic insults,
* pregnant and lactating females
35 Years
65 Years
ALL
No
Sponsors
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Menoufia University
OTHER
Responsible Party
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Dalia Salah Saif
Assistant professor of physical medicine,rheumatology and rehabilitation.
Locations
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Dalia Salah Saif
Menoufia Governorate, MD, Egypt
Countries
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Other Identifiers
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1478
Identifier Type: -
Identifier Source: org_study_id
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