Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT05900466
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05900466
Study Brief:
Protocol Section:
NCT05900466