Gouty ArthritisMets in goutNCT05332795
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
A study testing Metformin in people with Gouty Arthritis, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Gouty Arthritis
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2022to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gouty patients who fulfilled the American College of Rheumatology clinical criteria.
- gouty patients with active inflammatory arthritis.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Gouty Arthritis
- Being tested
- Metformin, Placebo
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.
PlaceboDrug
gouty patients, will receive placebo tablets once daily for about 3 months.
| Study group | Role | What they receive |
|---|---|---|
| group 1: gouty patients on metformin. | Active comparator | metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. Receives: Drug: Metformin |
| gouty patients on placebo. | Placebo comparator | placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological remission criteria
by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.
Measured: at 3 months post intervention.
Articular remission criteria
by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..
Measured: at 3 months post intervention.
Clinical remission criteria
by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale
Measured: at 3 months post intervention.
Secondary outcomes (1)
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.
Measured: at 3 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start28 Jun 2022
- Primary completion31 Dec 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gouty ArthritisStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Salah Saif, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332795
- Sponsor's protocol ID
- 1478
- Acronym
- Mets in gout
- Status last verified
- Mar 2024
- First submitted
- 2 Apr 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
- ClinicalTrials.gov ID
- NCT05332795
- Acronym / sponsor ID
- Mets in gout / 1478
- Conditions
- Gouty Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: gouty patients on metformin. | Active comparator | Drug: Metforminmetformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. |
| gouty patients on placebo. | Placebo comparator | Drug: Placeboplacebo users: include gouty patients, who were on placebo tablets once daily for about 3 months. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- gouty patients who fulfilled the American College of Rheumatology clinical criteria.
- gouty patients with active inflammatory arthritis.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformingouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months. | Drug | group 1: gouty patients on metformin. |
| Placebogouty patients, will receive placebo tablets once daily for about 3 months. | Drug | gouty patients on placebo. |
Primary outcome
Serological remission criteria
Time frame: at 3 months post intervention.
by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.
Articular remission criteria
Time frame: at 3 months post intervention.
by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..
Clinical remission criteria
Time frame: at 3 months post intervention.
by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale
1 secondary outcome
Gout Impact Scale (GIS)
Time frame: at 3 months post intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Gouty Arthritis, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological remission criteria (time frame: at 3 months post intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.