Mets in gout: The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: group 1: gouty patients on metformin. metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. |
Drug: Metformin
gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.
|
| Placebo Comparator: gouty patients on placebo. placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months. |
Drug: Placebo
gouty patients, will receive placebo tablets once daily for about 3 months.
|
Outcome Measures
Primary Outcome Measures
- Serological remission criteria [at 6 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 6 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 6 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
- Gout Impact Scale (GIS) [at 6 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 Outcome Measures
- Health-related quality of life HRQOL [at 6 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.
Eligibility Criteria
Criteria
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,
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Patients with hyperlipidemia, coronary artery disease,
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Patients with renal or hepatic insults,
-
pregnant and lactating females
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dalia Salah Saif | Menoufia Governorate | MD | Egypt | 123455 |
Sponsors and Collaborators
- Menoufia University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1478