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Anti-diabetic drug
Metformin for Fibromyalgia
Phase 2
Recruiting
Led By Akiko Okifuji, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-14 weeks
Awards & highlights
Study Summary
This trial will study if low-dose metformin can improve fibromyalgia symptoms by altering neuroinflammatory pathways. It'll compare those taking the medication to those taking a placebo.
Who is the study for?
This trial is for individuals who can follow English instructions, take oral medication, and adhere to a daily regimen. Participants must meet the criteria for Fibromyalgia Syndrome as per the American College of Rheumatology 2016. Those with diabetes, pregnancy or planning to become pregnant, serious organ diseases, autoimmune disorders, neuropathic pain, terminal illness-related pain or using weight control meds cannot join.Check my eligibility
What is being tested?
The INFORM Trial is testing if low-dose metformin improves fibromyalgia symptoms by affecting neuroinflammatory pathways. It compares the effects of metformin against a placebo in improving symptoms and altering certain cellular markers related to inflammation and pain signaling.See study design
What are the potential side effects?
While not specified here, common side effects of metformin include digestive issues like nausea and diarrhea; it may also cause vitamin B12 deficiency over time. Side effects are generally mild but vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS
Secondary outcome measures
Examine adherence
Examine changes in ecological momentary assessment (EMA) symptoms
Examine changes in individual FMS symptoms - Anxiety
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: 1: Metformin TreatmentActive Control1 Intervention
500 mg metformin ER tablets once daily in the morning with a glass of water for 8 weeks.
Group II: 2: PlaceboPlacebo Group1 Intervention
Matching metformin ER placebo tablets once daily in the morning with a glass of water for 8 weeks.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,100 Previous Clinical Trials
1,778,829 Total Patients Enrolled
5 Trials studying Fibromyalgia
440 Patients Enrolled for Fibromyalgia
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
485 Previous Clinical Trials
1,086,828 Total Patients Enrolled
26 Trials studying Fibromyalgia
13,448 Patients Enrolled for Fibromyalgia
Akiko Okifuji, PhDPrincipal InvestigatorUniversity of Utah
3 Previous Clinical Trials
360 Total Patients Enrolled
3 Trials studying Fibromyalgia
360 Patients Enrolled for Fibromyalgia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another worsening illness as diagnosed by a doctor.I have an autoimmune disorder like rheumatoid arthritis.I have pain from a terminal illness or specific organ damage.I have been diagnosed with nerve pain.I am not pregnant nor planning to be in the next year.I have a heart, liver, kidney, or lung disease diagnosed by a doctor.I am currently taking medication to control my weight.My kidney function is reduced, with an eGFR below 45.I have diabetes.I can take pills and will follow a daily metformin plan.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit of this investigation greater than twenty years?
"This medical experiment is welcoming individuals over 18 years of age and under 65 into the study."
Answered by AI
Is my profile suitable for the requirements of this research trial?
"To participate, individuals must have a confirmed diagnosis of fibromyalgia and be between 18 to 65 years old. A total of 72 patients are eligible for this clinical trial."
Answered by AI
Has the Food and Drug Administration sanctioned 1: Metformin Treatment?
"Metformin Treatment is deemed a moderate risk, scoring 2 on our scale from 1 to 3. This assessment was made as current evidence suggests the treatment's safety but not its efficacy at this stage of clinical trials."
Answered by AI
Are there any remaining openings in the trial for prospective participants?
"According to clinicaltrials.gov, this medical experiment is not currently accepting enrolment. The trial was initially made available on April 1st 2023 and last updated June 2nd 2023; nevertheless, there are a total of 110 other studies actively recruiting patients now."
Answered by AI
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