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

This study has been terminated.
(Difficulty in Recruitment)
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier:
NCT00982293
First received: September 21, 2009
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Device: Resonator device
Device: Resonator device - sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by pico-tesla Magnetic Therapies, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: September 2009
Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active fields 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.
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".
Device: Resonator device - sham
Treatment, 3 times weekly for 13 weeks (39) sessions - device will not be "on"

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982293

Locations
United States, Colorado
pico-tesla Magnetic Therapies
Littleton, Colorado, United States, 80120
Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
  More Information

No publications provided

Responsible Party: Allen S. Braswell CEO, pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT00982293     History of Changes
Other Study ID Numbers: 09109-01
Study First Received: September 21, 2009
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014