Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients

Phase 2

Recruiting

• Conditions: Gout
• Interventions: Drug: Febuxostat Tablets; Drug: Metformin

• Registration Number: NCT06995339
• Lead Sponsor: Mostafa Bahaa

Brief Summary

Gout is a systemic disease that results from the deposition of monosodium urate crystals (MSU) in tissues. Increased serum uric acid (SUA) above a specific threshold (\>6.8 mg/dl) is a requirement for the formation of uric acid crystals. MSU crystals can be deposited in all tissues mainly in and around the joints forming tophi. Early presentation of gout is an acute joint inflammation that is quickly relieved by non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Lowering SUA levels below deposition threshold either by dietary modification or using serum uric acid lowering drugs is the main goal in management of gout. This results in dissolution of MSU crystals preventing further attacks

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Study First Posted: 2025-05-29
• Study Start: 2025-05-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-21
• Last Update Posted: 2025-06-24
• Primary Completion: 2026-08-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males or females aged < 18 years.
• All patients are diagnosed to have gout with serum uric acid < 7 mg/dl.
• All patients are diagnosed to have obesity with body mass index (BMI) ≥ 30 kg/m2.

Exclusion Criteria

• The presence of any type of diabetes mellitus.
• Patients with drug-induced hyperuriceamia (those taking anti-TB agents, low dose aspirin, cytotoxic chemotherapy, diuretics, immunosuppressants, fructose, lactate infusion, testosterone or xylitol).
• Non-obese patients with BMI >30 kg/m2.
• Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Febuxostat Tablets	patients will receive febuxostat 80 mg daily for 6 months.
Metformin group	Febuxostat Tablets	patients will receive metformin 1000 mg daily for 6 months
Metformin group	Metformin	patients will receive metformin 1000 mg daily for 6 months

Primary Outcome Measures

Name	Time	Method
Change in serum uric acid level	3 months	Serum uric acid is the major metabolite of purine pathway and used in diagnosis of gouty patients

Trial Locations

Locations (1)

Mostafa Bahaa; 🇪🇬 Damietta, New Damietta, Egypt