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NCT02500628 · ClinicalTrials.gov registry record · Phase 2
Heart Rate Variability in Response to Metformin Challenge
A Phase 2 study of Diabetes Mellitus, Type 2 and Fibromyalgia, sponsored by Woodinville Psychiatric Associates.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT02500628: Completed Phase 2 study of Diabetes Mellitus, Type 2 and Fibromyalgia, sponsored by Woodinville Psychiatric Associates.
NCT02500628 is a Phase 2 study of Diabetes Mellitus, Type 2 and Fibromyalgia that has completed, run by Woodinville Psychiatric Associates. The registered enrollment target is 61 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02500628, a Phase 2 study of Diabetes Mellitus, Type 2 and Fibromyalgia, has completed, sponsored by Woodinville Psychiatric Associates.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Metformin
Study Locations (1)
Washington
- Woodinville Psychiatric Associates - Woodinville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT02500628 record still lists
NCT02500628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Metformin is the first listed.
NCT02500628 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT02500628 about?
NCT02500628 is a clinical study titled "Heart Rate Variability in Response to Metformin Challenge". 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 ...
What is the current status of trial NCT02500628?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2015-07. Estimated completion is 2016-02.
What conditions does trial NCT02500628 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Fibromyalgia, Movement Disorders, Mitochondrial Diseases.
What interventions are being tested in trial NCT02500628?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT02500628?
This trial is sponsored by Woodinville Psychiatric Associates, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02500628 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02500628's enrollment target sits among peer trials
61 244th of 348 higher than 104 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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