Metformin in Safety and Efficacy in Gouty Patients

NCT ID: NCT06924658

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-20

Study Completion Date

2026-11-20

Brief Summary

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The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double blinded

Study Groups

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Control group

this group will receive placebo in addition to the traditional lines of treatment of gout.

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type OTHER

Placebo will have the same look of metformin

Metformin group

This group will receive metformin (1000mg/day) in addition to the traditional lines of treatment of gout.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

Interventions

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placebo

Placebo will have the same look of metformin

Intervention Type OTHER

Metformin

Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.

Exclusion Criteria

* Systemic disorders such as cardiovascular, neurological, coronary artery disease.
* Hypertension, hyperlipidemia, diabetes mellitus, active infections.
* Other inflammatory or autoimmune diseases.
* Patients on biologics,
* Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mostafa Bahaa

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Bahaa

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tanta Unuversity

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Mostafa M I Bahaa, PhD

Role: primary

0201025538337

Other Identifiers

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8746

Identifier Type: -

Identifier Source: org_study_id

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