Phase 2
Completed N=61
Heart Rate Variability in Response to Metformin Challenge
Source: ClinicalTrials.gov NCT02500628 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Heart Rate Variability (Time Domain) — 0.92; 0.83 msec/msec — p=0.77
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.
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 |
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
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. Informational only — not medical advice.