Using metformin to improve fibromyalgia symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the safety and efficacy of low-dose metformin in improving symptoms associated with fibromyalgia syndrome (FMS). The study hypothesizes that patients receiving metformin will experience greater symptom relief compared to those on a placebo. The approach focuses on modulating neuroinflammatory pathways, which are believed to contribute to the chronic pain experienced by FMS patients. By targeting these pathways, the study seeks to provide a more effective treatment option for a condition that currently has limited therapeutic success.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* To be able to follow the protocol in English
* Fibromyalgia Syndrome: Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia
* Ability to take oral medication and be willing to adhere to the metformin regimen (once daily)

Exclusion Criteria:

* Co-occurring progressive disease (self-report, physician-diagnosed)
* Diabetes
* Pregnancy or planning to be pregnant in the next year (all premenopausal participants will be tested)
* Having known cardiovascular, liver, kidney or pulmonary diseases (self-report, physician-diagnosed)
* Having known serious psychopathology (Clinician diagnoses of psychosis, organic mental disorder, or dissociative disorder, self-reported active suicidal intent, self-reported history of inpatient admission to a psychiatric ward in the past year, evidence or self-report of self-injurious behaviors in the past year, reported current or recent history (2years) of non-IV substance abuse, any history of recreational IV drug use)
* Having autoimmune disorder (e.g., rheumatoid arthritis) (self-report, physician-diagnosed)
* Having neuropathic pain (self-report, physician-diagnosed)
* Having pain associated with a terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer) (self-report, physician-diagnosed)
* Concurrent use of weight controlling medications (eg, Xenical)
* Requiring an interpreter to communicate
* Abnormal levels of creatinine, vitamin B12, or hepatic function panel
* eGFR of below 45mL/min/1.73m2

Where it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Akiko Okifuji, PhD — University of Utah
• Study coordinator: Reiko Mitsunaga, RN
• Email: reiko.mitsunaga@hsc.utah.edu
• Phone: 801-585-7695

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Yishen Shujin Decoction for adults with fibromyalgia.

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• Effect of raising a child with ADHD on mothers' fibromyalgia burden

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• Forward head posture and symptom severity in fibromyalgia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.