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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.
Doctors need to develop tests which inexpensively and reliably evaluates brain metabolism. Current diagnostic tests sample other tissues which often run on different fuels (fats), utilize unproven and often insensitive brain imaging scanners, or sequence thousands to millions of base-pairs of DNA. All of these tests are expensive. None of these tests accurately or completely capture the interactions between the 1000s of proteins involved in brain metabolism.
The investigators suspect that mathematical analysis of the resting heart rate may provide some insight into brain metabolism. The brain controls heart rate in response to changes in blood pressure and blood gases like carbon dioxide and oxygen. Tight control of heart rate is necessary to make sure that the brain has the right mix of fuel and air. Because the brain can't respond instantly to changes in its fuel supply, this system acting as a biological carburetor has a natural oscillatory rhythm that can be monitored just like frequencies on the radio.
The investigators propose to amplify these rhythms by modestly metabolically stressing the brain with metformin, a inhibitor of complex 1 in the mitochondria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia | Experimental | Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning |
|
| Antipsychotic use | Experimental | Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 500 mg orally after baseline testing of heart rate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability (Time Domain) | ratio of the standard deviation of sampled intervals between each heart beat for ten minutes at time 1 (prior to metformin ingestion) over standard deviation of the sampled intervals between each heart beat for ten minutes at time 2 (2 hours post metformin ingestion) | difference pre/post metformin ingestion (2 hours) |
| Heart Rate Variability (Frequency Domain) | total power in the frequency domain is estimated for 10 minutes prior to metformin ingestion and then divided by the total power in the frequency domain estimated for 10 minutes 2 hours after metformin ingestion. Ratio is log-transformed. | difference pre/post metformin ingestion (2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Side Effects From the Medication | Patient after testing generated an unprompted list of observed side effects from the medication. Many reported none. Results were scored as the binary presence or absence of side effect | 2 hours after ingestion |
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Inclusion Criteria:
EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E Berner, MD PhD | Woodinville Psychiatric Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodinville Psychiatric Associates | Woodinville | Washington | 98072 | United States |
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7/25/2015 to 2/21/16
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibromyalgia | Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning Metformin: 500 mg orally after baseline testing of heart rate |
| FG001 | Antipsychotic Use | Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning Metformin: 500 mg orally after baseline testing of heart rate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibromyalgia | Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM Metformin: 500 mg po after baseline testing of heart rate |
| BG001 | Antipsychotic Use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate Variability (Time Domain) | ratio of the standard deviation of sampled intervals between each heart beat for ten minutes at time 1 (prior to metformin ingestion) over standard deviation of the sampled intervals between each heart beat for ten minutes at time 2 (2 hours post metformin ingestion) | Patients with or without fibromyalgia, with or without antipsychotic use. | Posted | Mean | Standard Deviation | msec/msec | difference pre/post metformin ingestion (2 hours) |
|
2 hours after ingestion of metformin
Patients provide an unstructured summary of possible side effects. Most reported none. Common side effects of GI distress or somnolence were scored as binary presence or absence
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibromyalgia | Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM Metformin: 500 mg po after baseline testing of heart rate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI distress | Gastrointestinal disorders | Non-systematic Assessment | Nausea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon Berner MD PhD | Woodinville Psychiatric Associates | 425-481-0429 | jonbernermd@gmail.com |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D028361 | Mitochondrial Diseases |
| D009069 | Movement Disorders |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D000071057 | Tardive Dyskinesia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM
Metformin: 500 mg po after baseline testing of heart rate
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM Metformin: 500 mg po after baseline testing of heart rate |
|
|
|
| Primary | Heart Rate Variability (Frequency Domain) | total power in the frequency domain is estimated for 10 minutes prior to metformin ingestion and then divided by the total power in the frequency domain estimated for 10 minutes 2 hours after metformin ingestion. Ratio is log-transformed. | patients with or without fibromyalgia. with or without antipsychotic use | Posted | Mean | Standard Deviation | ratio | difference pre/post metformin ingestion (2 hours) |
|
|
|
|
| Secondary | Number of Patients Reporting Side Effects From the Medication | Patient after testing generated an unprompted list of observed side effects from the medication. Many reported none. Results were scored as the binary presence or absence of side effect | Posted | Count of Participants | Participants | 2 hours after ingestion |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 13 |
| 38 |
| EG001 | Antipsychotic Use | Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM Metformin: 500 mg po after baseline testing of heart rate | 0 | 23 | 0 | 23 | 9 | 23 |
| drowsiness | Nervous system disorders | Non-systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002493 | Central Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |