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

NCT06995339 | Recruiting Phase 2

• 1 other identifier: 58479
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Gout

Outcome Measures

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

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

patients will receive febuxostat 80 mg daily for 6 months.

Drug: Febuxostat Tablets

Metformin group

ACTIVE COMPARATOR

patients will receive metformin 1000 mg daily for 6 months

Drug: Febuxostat Tablets; Drug: Metformin

Interventions

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

Control group; Metformin group

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)

Metformin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mostafa Bahaa: lead
• 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

Study Sites (1)

Mostafa Bahaa

Damietta, New Damietta, 34518, Egypt

RECRUITING

MeSH Terms

Conditions

Gout

Interventions

Febuxostat; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

EG (1)