Testing Low-Dose Metformin as a New Treatment for Fibromyalgia Symptoms A Phase 2 Randomized, Double-Blind Trial at University of Utah

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.

Metformin for Fibromyalgia Symptoms (INFORM Trial)