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The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients. (Mets in gout)

Primary Purpose

Gouty Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gouty Arthritis

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gouty patients who fulfilled the American College of Rheumatology clinical criteria.
  • gouty patients with active inflammatory arthritis.

Exclusion Criteria:

  • Patients with any type of inflammatory arthritis.
  • Patients with systemic disease as diabetes, hypertension,
  • Patients with hyperlipidemia, coronary artery disease,
  • Patients with renal or hepatic insults,
  • pregnant and lactating females

Sites / Locations

  • Dalia Salah SaifRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group 1: gouty patients on metformin.

gouty patients on placebo.

Arm Description

metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months.

placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.

Outcomes

Primary Outcome Measures

Serological remission criteria
by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.
Articular remission criteria
by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..
Clinical remission criteria
by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale

Secondary Outcome Measures

Gout Impact Scale (GIS)
by measuring GIS score, as higher scores in the GIS (range 0-100) imply a greater restriction of activity and a greater impact of gout and vice versa.

Full Information

First Posted
April 2, 2022
Last Updated
June 18, 2022
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05332795
Brief Title
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Acronym
Mets in gout
Official Title
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality. Methods: A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
Detailed Description
Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways. Objective: To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality. Methods: A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gouty Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1: gouty patients on metformin.
Arm Type
Active Comparator
Arm Description
metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months.
Arm Title
gouty patients on placebo.
Arm Type
Placebo Comparator
Arm Description
placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
gouty patients, will receive placebo tablets once daily for about 3 months.
Primary Outcome Measure Information:
Title
Serological remission criteria
Description
by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.
Time Frame
at 6 months post intervention.
Title
Articular remission criteria
Description
by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..
Time Frame
at 6 months post intervention.
Title
Clinical remission criteria
Description
by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale
Time Frame
at 6 months post intervention.
Secondary Outcome Measure Information:
Title
Gout Impact Scale (GIS)
Description
by measuring GIS score, as higher scores in the GIS (range 0-100) imply a greater restriction of activity and a greater impact of gout and vice versa.
Time Frame
at 6 months post intervention.
Other Pre-specified Outcome Measures:
Title
Health-related quality of life HRQOL
Description
Health-related quality of life HRQOL was assessed using the SF-36 subscale of physical functioning (PF-10), as Lower PF-10 scores (range 0-100) imply more functional limitations, and vice versa.
Time Frame
at 6 months post intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gouty patients who fulfilled the American College of Rheumatology clinical criteria. gouty patients with active inflammatory arthritis. Exclusion Criteria: Patients with any type of inflammatory arthritis. Patients with systemic disease as diabetes, hypertension, Patients with hyperlipidemia, coronary artery disease, Patients with renal or hepatic insults, pregnant and lactating females
Facility Information:
Facility Name
Dalia Salah Saif
City
Menoufia Governorate
State/Province
MD
ZIP/Postal Code
123455
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalia S Saif
Phone
01008312704
Email
sdalia30@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

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