Clinical trial NCT05332795: The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Official title: The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gouty Arthritis
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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,
* Patients with hyperlipidemia, coronary artery disease,
* Patients with renal or hepatic insults,
* pregnant and lactating females

Primary outcomes:
measure: Serological remission criteria
timeFrame: at 3 months post intervention.
measure: Articular remission criteria
timeFrame: at 3 months post intervention.
measure: Clinical remission criteria
timeFrame: at 3 months post intervention.
Secondary outcomes:
measure: Gout Impact Scale (GIS)
timeFrame: at 3 months post intervention.
Other outcomes:
measure: Health-related quality of life HRQOL
timeFrame: at 3 months post intervention.
Locations:
city: Menoufia Governorate
country: Egypt
facility: Dalia Salah Saif
state: MD
Study officials:
References: