Actively Recruiting
Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients
Led by Mostafa Bahaa · Updated on 2025-06-24
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
M
Mostafa Bahaa
Lead Sponsor
D
Dalia Naser Abdel-Sadek Safa , Faculty of Pharmacy, Tanta University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gout is a systemic condition caused by the buildup of monosodium urate crystals in tissues, especially around joints, resulting from high serum uric acid levels above 6.8 mg/dl. This research aims to compare the effects of two drugs, Metformin and Febuxostat, on obese patients with gout who do not have diabetes. The study is a phase 2 randomized trial assessing how these treatments impact gout management by lowering serum uric acid levels. Participants will be randomly assigned to one of two groups. One group will receive Febuxostat 80 mg daily, a drug that inhibits uric acid production, for six months. The other group will take Metformin 1000 mg daily, a medication usually used for diabetes but being studied here for its potential effects on gout, also for six months. Both treatments are being compared under double-blind conditions to evaluate their effects on gouty obese non-diabetic patients. During the study, participants will have their serum uric acid levels measured, with the primary outcome being the change at three months. The study will monitor biochemical and clinical changes over the six months of treatment. Patients will be assessed to see how these medications influence gout symptoms and uric acid levels, with safety and effectiveness carefully observed throughout the trial period.
CONDITIONS
Brief Title
Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Diagnosed with gout with serum uric acid less than 7 mg/dl
- Obese with body mass index (BMI) of 30 kg/m2 or higher
You will not qualify if you...
- Presence of any type of diabetes mellitus
- Use of medications causing drug-induced hyperuricemia (such as anti-TB agents, low dose aspirin, chemotherapy, diuretics, immunosuppressants, fructose, lactate infusion, testosterone, or xylitol)
- Non-obese patients with BMI less than 30 kg/m2
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either febuxostat 80 mg daily or metformin 1000 mg daily for 6 months.
Monthly visits during treatment
Trial Site Locations
Total: 1 location
1
Mostafa Bahaa
Damietta, New Damietta, Egypt, 34518
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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