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

Mostafa Bahaa

Status and phase: Enrolling; Phase 2

Conditions: Gout

Treatments: Drug: Febuxostat Tablets; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06995339

58479

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

patients will receive febuxostat 80 mg daily for 6 months.

Treatment:

Drug: Febuxostat Tablets

Metformin group

Active Comparator group

Description:

patients will receive metformin 1000 mg daily for 6 months

Treatment:

Drug: Metformin

Drug: Febuxostat Tablets