Heart Rate Variability in Response to Metformin Challenge

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Woodinville Psychiatric Associates
• Treatments: Metformin

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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