RecruitingPhase 2NCT05900466

Metformin for Fibromyalgia Symptoms (INFORM Trial)

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


Sponsor

University of Utah

Enrollment

72 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Metformin and a drug called Placebo for people with fibromyalgia syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

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

DRUGPlacebo

Matching tablets once daily in the morning for 8 weeks


Locations(1)

University of Utah

Salt Lake City, Utah, United States

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NCT05900466


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