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RECRUITING
NCT05900466
PHASE2

Metformin for Fibromyalgia Symptoms (INFORM Trial)

Sponsor: University of Utah

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2023-04-01

Completion Date

2027-03-31

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Metformin

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

DRUG

Placebo

Matching tablets once daily in the morning for 8 weeks

Locations (1)

University of Utah

Salt Lake City, Utah, United States