Health TrialsbyHealthPanel

Metformin for Fibromyalgia Symptoms (INFORM Trial)

ConditionFibromyalgia Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Utah

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin

    Drug

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

  • Placebo

    Drug

    Matching tablets once daily in the morning for 8 weeks

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: 1: Metformin TreatmentActive comparator 1 intervention
Group B: 2: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS

Safety will be measured by the Fibromyalgia Impact Questionnaire, Revised (FIQ-R score and will measure overall FMS severity. The numeric scale ranges from 0-10 with 0 being "low difficulty" (better outcome) and 10 being "high difficulty" (worse outcome).

Time frame
12-14 weeks

Secondary outcomes

1

Examine changes in individual FMS symptoms - Pain Intensity

Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of pain intensity (PROMIS Pain Intensity SF3a). The scale ranges from 0-10, 0 being "no pain" (better outcome) and 10 being "worst pain imaginable" (worse outcome).

Time frame
12-14 weeks
2

Examine changes in individual FMS symptoms - Fatigue

Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of fatigue (PROMIS Fatigue SF7a). The scale ranges from 1-5, 1 being "not at all" (better outcome) and 5 being "very much" (worse outcome).

Time frame
12-14 weeks
3

Examine changes in individual FMS symptoms - Sleep Disturbance

Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of sleep disturbance (PROMIS Sleep Disturbance SF8b). The scale ranges from 1-5, 1 being "very poor" or "not at all" (worse outcome) and 5 being "very good" or "very much" (better outcome).

Time frame
12-14 weeks
4

Examine changes in individual FMS symptoms - Depression

Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of depression (PROMIS Depression SF8b). The scale ranges from 1-5, 1 being "never" (better outcome) and 5 being "always" (worse outcome).

Time frame
12-14 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
Apply now