The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

Gouty Arthritis Clinical Trial

— Mets in gout  

Official title:

The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332795
• Other study ID #: 1478
• Status: Completed
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 20, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Gouty Arthritis

Intervention

Drug:
• Metformin
gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.
• Placebo
gouty patients, will receive placebo tablets once daily for about 3 months.

Locations

Country	Name	City	State
Egypt	Dalia Salah Saif	Menoufia Governorate	MD

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related quality of life HRQOL	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.	at 3 months post intervention.
Primary	Serological remission criteria	by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.	at 3 months post intervention.
Primary	Articular remission criteria	by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..	at 3 months post intervention.
Primary	Clinical remission criteria	by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale	at 3 months post intervention.
Secondary	Gout Impact Scale (GIS)	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.	at 3 months post intervention.