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NCT Number: NCT06995339

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

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

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mostafa Bahaa

Damietta, New Damietta, 34518, Egypt

Location status: Recruiting

Location contact

Mostafa Bahaa, PhD

CONTACT

[email protected]

0201025538337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Change in serum uric acid level

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Mostafa Bahaa

Other

Collaborators

  • Dalia Naser Abdel-Sadek Safa , Faculty of Pharmacy, Tanta University
  • Sahar Mohamed Elhaggar, Faculty of Pharmacy, Tanta University
  • Tarek Mohamed Abd-Elazez Nasr-Allah, Faculty of Medicine - Al-Azhar University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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