Actively Recruiting
Metformin as a Novel, Mechanistic Treatment of Fibromyalgia; a Proof of Concept Randomized Controlled Trial
Led by University of Utah · Updated on 2026-03-30
72
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating the safety and effectiveness of low-dose metformin to improve symptoms related to fibromyalgia syndrome (FMS), a chronic pain condition affecting about 10 million Americans. The study focuses on how metformin may influence neuroinflammatory pathways, which are believed to play a key role in the pain and other symptoms of FMS. The trial aims to see if metformin can reduce symptom severity by affecting specific biological markers linked to inflammation and pain sensitivity. Participants will take either 500 mg of extended-release metformin or a matching placebo once daily in the morning for 8 weeks. The study is randomized and double-blinded, meaning neither participants nor researchers know who receives metformin or placebo during the treatment phase. The goal is to compare symptom improvement between the metformin group and the placebo group over this period. During the study, participants will be assessed for changes in pain intensity, fatigue, sleep disturbances, depression, anxiety, physical function, and cognitive function over 12 to 14 weeks. Researchers will also monitor safety and adherence to the medication regimen. The study includes blood tests to measure immune cell activity and other biological markers, with follow-up visits to track symptoms and treatment effects throughout the trial period.
CONDITIONS
Brief 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
- Diagnosed with Fibromyalgia Syndrome according to the American College of Rheumatology 2016 revised criteria
- Able to take oral medication and willing to follow the daily metformin regimen for 8 weeks
- Aged between 18 and 75 years
You will not qualify if you...
- Having a progressive disease diagnosed by self-report or physician
- Diagnosis of diabetes
- Pregnant or planning pregnancy within the next year (all 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, self-injurious behavior, substance abuse, or history of recreational IV drug use
- Autoimmune disorders such as rheumatoid arthritis
- Neuropathic pain diagnosis
- Pain related to terminal illness, acute pain, or specific organ damage such as stomach ulcers
- Use of weight control medications like Xenical
- Need for an interpreter to communicate
- Abnormal kidney function, vitamin B12 levels, or liver function tests
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m2
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take metformin or placebo tablets once daily in the morning for 8 weeks to evaluate the effect on fibromyalgia symptoms.
Visits occur at Week 4 and Week 8 during treatment
Duration - 4 to 6 weeks after treatment
Participants are monitored for safety, efficacy, and adherence to treatment during a follow-up period.
1 visit at approximately Week 14
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
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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