The Application of Extremely Low Level Magnetic Fields as Adjunctive Treatment for Type II Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes Mellitus, Pilot Study II

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Resonator device
* Device: Resonator device - sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current diagnosis of Type 2 Diabetes Mellitus with a hemoglobin A1c level above 7.5%, despite management of diabetes with diet and/or medication. Subject currently performs routine finger stick blood sugar testing as part of his or her current diabetes disease management regimen. Subject is ambulatory Subject is on stable oral medication regimen without significant side effects for at least three (3) months (stable insulin regimen NOT permissible); willingness and ability to maintain the stable oral medication regimen throughout the course of the study. If on agents suspected of contributing to hyperglycemia(see list below), subject must have been on a stable dose of this(these) agent(s) for 6 months prior to study initiation. Hemoglobin A1c levels within a 0.8 % range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date. Willingness to test finger stick blood sugars according to prescribed protocol. Willingness to have lab test blood draws performed according to prescribed protocol Willingness to maintain stable diet and activity regimen for the duration of the study. Willing and able to abstain from partaking in any non-essential (not physician ordered) existing or new treatments to improve serum blood sugar levels Willing and able to abstain from all medications that could affect diabetes mellitus and/or any of its associated symptoms for the duration of the study Adequate contraceptive measures for females subjects Any ethnic background Exclusion Criteria: Change in medical regimen within 3 months prior to initiation of study. Any signs of type 1 diabetes mellitus (including any history of ketoacidosis or new requirement for insulin therapy within the 6 month period prior to study initiation). Active significant infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level Change in BMI of greater than 6 % within a 3 month period prior to study initiation Any planned revascularization procedure. Symptomatic congestive heart failure. Leg or foot ulceration or open wounds Gangrene. History of intermittent claudication Hemodialysis Currently being treated for malignancy Currently being treated with oral or intravenous catabolic steroids Reported consumption of more than 14 alcoholic drinks per week. Pregnant, breast feeding, or planning pregnancy prior to the end of participation Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements Uncontrolled hypertension Uncontrolled atrial fibrillation or other uncontrolled arrythmias, e.g. tachycardia, bradycardia Uncontrolled seizure disorder Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subject's health or ability to complete the entire study, in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active fields<br> | Device: Resonator device<br>* Low level electromagnetic fields for whole body immersion, 3 times weekly for 13 weeks (39) sessions of approximately 11/2 hours each.<br>|
| Sham Comparator: Inactive device<br>Placebo treated group, will receive the 3 times weekly for 13 weeks (39) sessions, however, the device will not be on. | Device: Resonator device - sham<br>* Treatment, 3 times weekly for 13 weeks (39) sessions - device will not be on<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |