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Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863954
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : December 15, 2010
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC

Brief Summary:
The purpose of this study is to see if using a device called the Resonator, that puts out a very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2 Diabetes.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Device: Resonator Device Phase 1

Detailed Description:
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant reductions in finger stick blood glucose levels, serum glucose and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids and liver function tests as indirect markers of insulin resistance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: A Controlled Pilot Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes
Study Start Date : January 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Output A Device: Resonator Device
comparison of different parameter settings of electromagnetic fields using the Resonator Device

Active Comparator: Output B Device: Resonator Device
comparison of different parameter settings of electromagnetic fields using the Resonator Device

Active Comparator: Output C Device: Resonator Device
comparison of different parameter settings of electromagnetic fields using the Resonator Device

Active Comparator: Output D Device: Resonator Device
comparison of different parameter settings of electromagnetic fields using the Resonator Device

Active Comparator: Output E Device: Resonator Device
comparison of different parameter settings of electromagnetic fields using the Resonator Device

Active Comparator: Output F Device: Resonator Device
comparison of different parameter settings of electromagnetic fields using the Resonator Device




Primary Outcome Measures :
  1. Reduction in blood glucose and A1c levels at endpoint compared to start [ Time Frame: Start point, 3 months and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of Type II Diabetes Mellitus with A1c level above the upper limit of normal
  • Subject currently performs routine finger stick blood sugar testing
  • Subject is ambulatory
  • None or stable medication regimen without significant side effects for at least 6 months, willingness and ability to maintain the stable medication regimen throughout the course of the study.
  • 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 protocol.
  • Willingness to have lab test blood draws performed according to 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 existing or new treatments to improve serum blood sugar levels.
  • Adequate contraceptive measures for female subjects
  • Male or female
  • Any ethnic group
  • Between 21 and 80 years of age

Exclusion Criteria:

  • Change in medical regimen within 6 months prior to initiation of study
  • Any signs of Type I diabetes
  • Active 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 6 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 subjects health or ability to complete the entire study, in the opinion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863954


Locations
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United States, Colorado
pico-tesla Magnetic Therapies
Littleton, Colorado, United States, 80120
Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
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Responsible Party: Allen S. Braswell CEO, pico-tesla Magnetic Therapies, LLC, pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT00863954    
Other Study ID Numbers: 08165-01
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases