Metformin for safety and benefit in people with gout
the Impact of Metformin Use on Clinical Outcomes in Gouty Patients
This trial will test whether metformin is safe and helps reduce gout symptoms in people diagnosed with gout.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT06924658 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares metformin to a placebo in people diagnosed with gout to gather safety and efficacy data. Participants will receive either metformin or placebo and be monitored for gout-related outcomes and adverse events over the treatment period. Key exclusions include patients with cardiovascular disease, hypertension, hyperlipidemia, diabetes, active infections, other inflammatory or autoimmune diseases, those on biologic therapies, and anyone with impaired liver or kidney function or metformin hypersensitivity. The trial is being conducted at a single site at Tanta University.
Who should consider this trial
Good fit: Ideal candidates are people clinically diagnosed with gout by ACR/EULAR criteria who do not have diabetes, hypertension, hyperlipidemia, cardiovascular or neurological disease, active infections, other inflammatory or autoimmune diseases, impaired liver or kidney function, current biologic therapy, or metformin hypersensitivity.
Not a fit: Patients with comorbid conditions listed as exclusions (such as diabetes, cardiovascular disease, impaired renal or liver function), those on biologics, or those allergic to metformin would be excluded and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, metformin could provide a low-cost, well-tolerated option to reduce gout flares and improve quality of life for people with gout.
How similar studies have performed: Metformin has shown anti-inflammatory and cardio-renal protective effects in observational and preclinical work, but its specific use to treat gout is largely untested in randomized clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout. Exclusion Criteria: * 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.
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.