RECRUITING

Metformin for Fibromyalgia Symptoms (INFORM Trial)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-04-01

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05900466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Reiko Mitsunaga, RN

CONTACT

801-585-7695

reiko.mitsunaga@hsc.utah.edu

Principal Investigator

Akiko Okifuji, PhD

PRINCIPAL_INVESTIGATOR

University of Utah

Norman Taylor, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Utah

Study Locations (Sites)

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: University of Utah

Akiko Okifuji, PhD, PRINCIPAL_INVESTIGATOR, University of Utah
Norman Taylor, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Fibromyalgia Syndrome