Recruiting
Phase 2

Metformin

Sponsor:

University of Utah

Code:

NCT05900466

Conditions

Fibromyalgia Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Metformin

Placebo

Study Details

Brief summary:

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

Fibromyalgia Syndrome

Study ID

NCT05900466

Start date

Apr 1, 2023

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1: Metformin Treatment

500 mg metformin ER tablets once daily in the morning with a glass of water for 8 weeks.

placebo comparator: 2: Placebo

Matching metformin ER placebo tablets once daily in the morning with a glass of water for 8 weeks.

Interventions

Metformin

500 mg Metformin ER tablets once daily in the morning for 8 weeks

Placebo

Matching tablets once daily in the morning for 8 weeks

Primary outcome measure

  • Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS [ Time Frame: 12-14 weeks ]

Central Contacts and Locations

Central contacts

Reiko Mitsunaga, RN

801-585-7695reiko.mitsunaga@hsc.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Reiko Mitsunaga, RN

801-585-7695reiko.mitsunaga@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • FMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of Utah on 2026-03-30.