RecruitingPhase 2NCT06995339

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

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


Sponsor

Mostafa Bahaa

Enrollment

60 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

DRUGFebuxostat Tablets

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

DRUGMetformin

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)


Locations(1)

Mostafa Bahaa

Damietta, New Damietta, Egypt

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NCT06995339


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