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Difficulty in Recruitment
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The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields, effects blood glucose and A1c levels in people with Type 2 Diabetes.
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator TM, as an adjunctive therapy to oral medications results in statistically significant reductions in fasting blood glucose levels, post prandial glucose levels and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active fields | Active Comparator |
| |
| Inactive device | Sham Comparator | Placebo treated group, will receive the 3 times weekly for 13 weeks (39) sessions, however, the device will not be "on". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resonator device | Device | Low level electromagnetic fields for whole body immersion, 3 times weekly for 13 weeks (39) sessions of approximately 11/2 hours each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is the improvement in Subject's hemoglobin A1c level after 13 weeks of treatment compared to baseline. | baseline, end of treatment (13 weeks) and 3 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| pico-tesla Magnetic Therapies | Littleton | Colorado | 80120 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Resonator device - sham | Device | Treatment, 3 times weekly for 13 weeks (39) sessions - device will not be "on" |
|
| D004700 | Endocrine System Diseases |