Metformin in Safety and Efficacy in Gouty Patients

NCT06924658 | Recruiting Phase 2

• 1 other identifier: 8746
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• - Clinical assessment of disease activity

  \- Clinical assessment of disease activity by assessing patient and physician VAS visual analog scale (0-10 cm);

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

this group will receive placebo in addition to the traditional lines of treatment of gout.

Other: placebo

Metformin group

ACTIVE COMPARATOR

This group will receive metformin (1000mg/day) in addition to the traditional lines of treatment of gout.

Drug: Metformin

Interventions

placebo OTHER

Placebo will have the same look of metformin

Control group

Metformin DRUG

Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

Metformin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.

You may not qualify if:

• Systemic disorders such as cardiovascular, neurological, coronary artery disease.
• Hypertension, hyperlipidemia, diabetes mellitus, active infections.
• Other inflammatory or autoimmune diseases.
• Patients on biologics,
• Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.

Sponsors & Collaborators

• Mostafa Bahaa: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Gout

Interventions

Metformin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 11, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

EG (1)