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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2019-01-09
2020-01-09
Brief Summary
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Direct and indirect anti-inflammatory effects of metformin have been reported in animal and clinical studies, and this effect is independent of its hypoglycemic effect.
Animal studies showed that metformin decreased serum C-reactive protein (CRP) level in atherogenic rabbits and decreased proinflammatory cytokines (interleukin (IL)-1β, IL-6 and tumor necrosis factor (TNF-α) in obese mice .
Moreover, metformin also suppressed osteoclastogenesis ; this may partially result from decreased expression of inflammatory cytokines that promote osteoclastogenesis in the arthritic joint.
The objective of this study is to evaluate the efficacy and safety of addition of metformin to standard disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Metformin Group
850 mg metformin twice daily for six months in addition to standard therapy
Metformin
metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
Conventional DMARDs
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
Control Group
placebo in addition to standard therapy for rheumatoid arthritis
Conventional DMARDs
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
Placebo Oral Tablet
oral tablet
Interventions
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Metformin
metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
Conventional DMARDs
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
Placebo Oral Tablet
oral tablet
Eligibility Criteria
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Inclusion Criteria
* Patients with moderate to high disease activity (DAS - 28 . score greater than 3.2)
* Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.
Exclusion Criteria
* Patients who have a prior diagnosis with diabetes mellitus.
* Patients receive metformin for any other indications.
* Patients with congestive heart failure.
* Patients with a history of myocardial infarction.
* Patients with severe anemia.
* Patients with active infections or other inflammatory diseases.
* Patients receiving biological therapy.
* Pregnancy or lactation.
* Patients with impaired liver functions.
* Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
* Patients with malignancies.
18 Years
ALL
No
Sponsors
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Future University in Egypt
OTHER
Ain Shams University
OTHER
Responsible Party
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Mahmoud Mustafa Mahmoud Gharib
Principal investigator
Locations
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Al-Zahraa University Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Mahmoud M Gharib
Role: primary
Other Identifiers
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215
Identifier Type: -
Identifier Source: org_study_id
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