Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes

Type II Diabetes Mellitus Clinical Trial

Official title:

A Controlled Pilot Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863954
• Other study ID #: 08165-01
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2009
• Last updated: December 14, 2010
• Start date: January 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• 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 a very low electromagnetic field, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

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 II Diabetes Mellitus

Intervention

Device:
• Resonator Device
comparison of different parameter settings of electromagnetic fields using the Resonator Device

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	Reduction in blood glucose and A1c levels at endpoint compared to start		Start point, 3 months and 6 months	No