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

Phase 2RecruitingNCT06995339

Mostafa Bahaa60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gout

Interventions

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

MetforminDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mostafa Bahaa

Damietta, New Damietta, Egypt

RECRUITING

Outcomes

Primary Outcomes

Change in serum uric acid level

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

Time frame: 3 months

Data from ClinicalTrials.gov

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