Gout
Conditions
Brief 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
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
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)
Sponsors
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
Mostafa Bahaa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum uric acid level | 3 months | Serum uric acid is the major metabolite of purine pathway and used in diagnosis of gouty patients |
Countries
Egypt
Outcome results
None listed