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The Application of Extremely Low Level 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: NCT00982293
Recruitment Status : Terminated (Difficulty in Recruitment)
First Posted : September 23, 2009
Last Update Posted : May 5, 2011
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC

Tracking Information
First Submitted Date  ICMJE September 21, 2009
First Posted Date  ICMJE September 23, 2009
Last Update Posted Date May 5, 2011
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
The primary outcome measure is the improvement in Subject's hemoglobin A1c level after 13 weeks of treatment compared to baseline. [ Time Frame: baseline, end of treatment (13 weeks) and 3 months post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Application of Extremely Low Level Magnetic Fields as Adjunctive Treatment for Type II Diabetes
Official Title  ICMJE 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
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Device: Resonator device
    Low level electromagnetic fields for whole body immersion, 3 times weekly for 13 weeks (39) sessions of approximately 11/2 hours each.
  • Device: Resonator device - sham
    Treatment, 3 times weekly for 13 weeks (39) sessions - device will not be "on"
Study Arms  ICMJE
  • Active Comparator: Active fields
    Intervention: Device: Resonator device
  • Sham Comparator: Inactive device
    Placebo treated group, will receive the 3 times weekly for 13 weeks (39) sessions, however, the device will not be "on".
    Intervention: Device: Resonator device - sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)
165
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00982293
Other Study ID Numbers  ICMJE 09109-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allen S. Braswell CEO, pico-tesla Magnetic Therapies, LLC
Study Sponsor  ICMJE pico-tesla Magnetic Therapies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account pico-tesla Magnetic Therapies, LLC
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP