Metformin as a Novel, Mechanistic Treatment of Fibromyalgia; a Proof of Concept RCT
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.
Description
Fibromyalgia syndrome (FMS) is a chronic pain condition that is debilitating to an estimated 10 million Americans and results in high utilization of medical resources with a cost of over $100 billion in health care and lost productivity each year. It is widely accepted that chronic widespread pain is a defining feature of FMS and that it is maintained by central sensitization. Accumulating evidence demonstrates that central sensitization is driven, at least in part, by neuroinflammation. Thus, molecules that ameliorate the causes of neuroinflammation are intriguing candidates to treat FMS symp…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugMetformin
500 mg Metformin ER tablets once daily in the morning for 8 weeks
- DrugPlacebo
Matching tablets once daily in the morning for 8 weeks
Location
- University of UtahSalt Lake City, Utah