Actively Recruiting
Metformin for Fibromyalgia Symptoms (INFORM Trial)
Led by University of Utah · Updated on 2026-03-30
72
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metformin for Fibromyalgia Symptoms (INFORM Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to follow the study protocol in English
- Meet the American College of Rheumatology 2016 revised criteria for fibromyalgia syndrome
- Able and willing to take oral medication once daily and adhere to the metformin regimen
You will not qualify if you...
- Having a progressive disease diagnosed by self-report or physician
- Having diabetes
- Pregnant or planning pregnancy in the next year (premenopausal participants will be tested)
- Known cardiovascular, liver, kidney, or lung diseases
- Serious psychiatric conditions including psychosis, organic mental disorder, dissociative disorder, active suicidal intent, recent psychiatric hospitalization, recent self-injurious behavior, recent substance abuse, or history of IV drug use
- Autoimmune disorders such as rheumatoid arthritis
- Neuropathic pain conditions
- Pain from terminal illness, acute pain, or specific organ damage like stomach ulcers
- Using weight control medications such as Xenical
- Needing an interpreter to communicate
- Abnormal kidney function, vitamin B12 deficiency, or liver function abnormalities
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m2
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
R
Reiko Mitsunaga, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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