Gouty Arthritis
Conditions
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.
Interventions
DRUGMetformin
gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.
DRUGPlacebo
gouty patients, will receive placebo tablets once daily for about 3 months.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life HRQOL | at 3 months post intervention. | Health-related quality of life HRQOL was assessed using the SF-36 subscale of physical functioning (PF-10), as Lower PF-10 scores (range 0-100) imply more functional limitations, and vice versa. |
Countries
Egypt
Outcome results
None listed