Metformin for Fibromyalgia Symptoms (INFORM Trial)

• Status: Active, not recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Metformin

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