The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
- Registration Number
- NCT05332795
- Lead Sponsor
- Menoufia University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- gouty patients who fulfilled the American College of Rheumatology clinical criteria.
- gouty patients with active inflammatory arthritis.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1: gouty patients on metformin. Metformin metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. gouty patients on placebo. Placebo placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.
- Primary Outcome Measures
Name Time Method Serological remission criteria at 3 months post intervention. by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.
Articular remission criteria 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..
Clinical remission criteria 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 Outcome Measures
Name Time Method Gout Impact Scale (GIS) 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.
Trial Locations
- Locations (1)
Dalia Salah Saif
🇪🇬Menoufia Governorate, MD, Egypt