Metformin as a Novel, Mechanistic Treatment of Fibromyalgia; a Proof of Concept RCT

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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)

Locations
United States
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Reiko Mitsunaga, RN
reiko.mitsunaga@hsc.utah.edu
801-585-7695
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 72
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov

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