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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00982293
• Other study ID #: 09109-01
• Status: Terminated
• Phase: Phase 2
• First received: September 21, 2009
• Last updated: May 4, 2011
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: pico-tesla Magnetic Therapies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 165
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• Resonator device - sham
Treatment, 3 times weekly for 13 weeks (39) sessions - device will not be "on"

Locations

Country	Name	City	State
United States	pico-tesla Magnetic Therapies	Littleton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
pico-tesla Magnetic Therapies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No