Using metformin to improve fibromyalgia symptoms
Metformin as a Novel, Mechanistic Treatment of Fibromyalgia; a Proof of Concept RCT
This study is testing if low-dose metformin can help people with fibromyalgia feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05900466 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with fibromyalgia syndrome who meet specific classification criteria and can adhere to a medication regimen.
Not a fit: Patients with co-occurring progressive diseases, diabetes, or serious psychopathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from fibromyalgia by alleviating their symptoms more effectively than current therapies.
How similar studies have performed: While the use of metformin for fibromyalgia is a novel approach, preclinical studies have shown promise in treating related symptoms, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Salt Lake City, Utah
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.