Clinical trial

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

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06995339

Recruiting nowPhase 2Interventional

What this study is 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionGout

Full registry criteria

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.

Treatments and study arms

Febuxostat Tablets

Drug

Febuxostat is a selective xanthine oxidase inhibitor (XOI) that targets uric acid generation. It has been used as a SUA lowering agent in patients not responding to allopurinol

Metformin

Drug

Metformin is an oral antihyperglycemic drug widely used in type 2 diabetes (T2DM) treatment. Most of its effects are exerted via an indirect induction of the phosphorylated activation of AMP-activated protein kinase (AMPK)

Primary outcomes

Change in serum uric acid level3 months

Serum uric acid is the major metabolite of purine pathway and used in diagnosis of gouty patients

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mostafa Bahaa🇪🇬 Damietta, New Damietta, Egypt
Mostafa Bahaa, PhDContact