Metformin for Fibromyalgia Symptoms (INFORM Trial)

Launched by UNIVERSITY OF UTAH · Jun 2, 2023

Keywords

ClinConnect Summary

The INFORM Trial is studying whether a low dose of metformin, a medication often used to treat diabetes, can help improve symptoms in people with Fibromyalgia Syndrome (FMS). The researchers believe that metformin may help reduce inflammation in the body, which could lead to less pain and discomfort for those with FMS. They will compare the effects of metformin with a placebo (a non-active treatment) to see if participants taking metformin feel better.

To join the trial, participants need to be between the ages of 18 and 65 and must meet specific criteria for fibromyalgia. They should be able to take medication by mouth and follow instructions in English. However, individuals with certain health conditions like diabetes, heart or kidney issues, or serious mental health problems will not be eligible. Participants can expect to take metformin daily and will be monitored by the research team throughout the study. This trial is currently recruiting participants, and it aims to find out if metformin can be a new treatment option for improving the quality of life for those living with fibromyalgia.

Gender

ALL

Eligibility criteria

• 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-diagnosed)
• • Having known serious psychopathology (Clinician diagnoses of psychosis, organic mental disorder, or dissociative disorder, self-reported active suicidal intent, self-reported history of inpatient admission to a psychiatric ward in the past year, evidence or self-report of self-injurious behaviors in the past year, reported current or recent history (2years) of non-IV substance abuse, any history of recreational IV drug use)
• • Having autoimmune disorder (e.g., rheumatoid arthritis) (self-report, physician-diagnosed)
• • Having neuropathic pain (self-report, physician-diagnosed)
• • Having pain associated with a terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer) (self-report, physician-diagnosed)
• • Concurrent use of weight controlling medications (eg, Xenical)
• • Requiring an interpreter to communicate
• • Abnormal levels of creatinine, vitamin B12, or hepatic function panel
• • eGFR of below 45mL/min/1.73m2