Heart Rate Variability in Response to Metformin Challenge

Completed · Phase 2

Conditions studied: Fibromyalgia, Mitochondrial Diseases, Movement Disorders, Diabetes Mellitus, Type 2

In brief

Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then provide an additional sample 2 hours later.

Key facts

Study ID

NCT02500628

Run by

Woodinville Psychiatric Associates

People needed

61

Starts

2015-07-01

Expected to finish

2016-02-01

Last updated by the study team

2018-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications

You may not qualify if…

• recent infection,
• renal failure,
• pre-existing cardiac disease,
• chronic obstructive pulmonary disease
• inability to participate in informed consent,
• lack of transport to return home from study site,
• severe fasting intolerance or hypoglycemia,
• history of stroke-alike episode,
• uncontrolled migraine or cyclic vomiting,
• diabetes on insulin or sulfonylurea,
• non-English speaker,
• medications with strong effects on baseline heart rate variability

Where it is running

• Woodinville Psychiatric Associates — Woodinville, Washington, United States

Full record on ClinicalTrials.gov

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