| Trial ID: | L6393 |
| Source ID: | NCT02500628
|
| Associated Drug: |
Metformin
|
| Title: |
Heart Rate Variability in Response to Metformin Challenge
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02500628/results
|
| Conditions: |
Fibromyalgia|Mitochondrial Diseases|Movement Disorders|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Metformin
|
| Outcome Measures: |
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), 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) | 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, 2 hours after ingestion
|
| Sponsor/Collaborators: |
Sponsor: Woodinville Psychiatric Associates
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
61
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2015-07
|
| Completion Date: |
2016-02
|
| Results First Posted: |
2018-01-03
|
| Last Update Posted: |
2018-01-03
|
| Locations: |
Woodinville Psychiatric Associates, Woodinville, Washington, 98072, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02500628
|
