NCT05900466 Metformin for Fibromyalgia Symptoms (INFORM Trial)
| NCT ID | NCT05900466 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Fibromyalgia Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 72 participants in total. It began in 2023-04-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of the project is to evaluate the safety and efficacy of low dose metformin for improving symptoms associated with fibromyalgia syndrome (FMS) via modulating neuroinflammatory pathways. The investigators hypothesize that FMS patients in the low-dose metformin conditions will show greater improvement in FMS symptoms than those who are in the placebo group. Further, the investigators hypothesize that metformin will increase phosphorylated AMPK in peripheral immune cells of FMS patients and will decrease the transcription of mTORC1, NLRP3 inflammasome, and nociceptive cytokines interleukin 1beta and interleukin 18.
Eligibility 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
Contact & Investigator
Akiko Okifuji, PhD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT05900466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Fibromyalgia Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05900466 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05900466 currently recruiting?
Yes, NCT05900466 is actively recruiting participants. Contact the research team at reiko.mitsunaga@hsc.utah.edu for enrollment information.
Where is the NCT05900466 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT05900466 clinical trial?
NCT05900466 is sponsored by University of Utah. The principal investigator is Akiko Okifuji, PhD at University of Utah. The trial plans to enroll 72 participants.
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