Phase 2 N=61 Diagnostic

Heart Rate Variability in Response to Metformin Challenge

Fibromyalgia · Mitochondrial Diseases · Movement Disorders · Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT02500628 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcome: Primary: Heart Rate Variability (Time Domain) — 0.92; 0.83 msec/msec — p=0.77

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Metformin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Woodinville Psychiatric Associates
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate Variability (Time Domain)	0.92; 0.83	0.77
PRIMARY Heart Rate Variability (Frequency Domain)	-.14; -.24	0.27
SECONDARY Number of Patients Reporting Side Effects From the Medication	13; 9	0.92

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02500628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.