Metformin for Fibromyalgia Symptoms (INFORM Trial)

Conditions

• Fibromyalgia Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Apr 1, 2023

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS [ Time Frame: 12-14 weeks ]

Central Contacts

• Reiko Mitsunaga, RN
  801-585-7695
  [email protected]

Locations (1)

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