Metformin for Fibromyalgia Symptoms (INFORM Trial)
ConditionFibromyalgia Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Utah
About this trial
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
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Metformin
- Placebo
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Utah
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov