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

ConditionGout
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMostafa Bahaa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Metformin groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mostafa Bahaa

Lead sponsor

Tanta University

Sponsor institution

Dalia Naser Abdel-Sadek Safa , Faculty of Pharmacy, Tanta University

Collaborator

Sahar Mohamed Elhaggar, Faculty of Pharmacy, Tanta University

Collaborator

Tarek Mohamed Abd-Elazez Nasr-Allah, Faculty of Medicine - Al-Azhar University

Collaborator

Source ClinicalTrials.gov
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