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Metformin for Fibromyalgia Symptoms (INFORM Trial)
Sponsor: University of Utah
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.
Official title: Metformin as a Novel, Mechanistic Treatment of Fibromyalgia; a Proof of Concept RCT
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2023-04-01
Completion Date
2027-03-31
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Metformin
500 mg Metformin ER tablets once daily in the morning for 8 weeks
Placebo
Matching tablets once daily in the morning for 8 weeks
Locations (1)
University of Utah
Salt Lake City, Utah, United States