NCT00982293

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started Sep 2009

Typical duration for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

September 21, 2009

Last Update Submit

May 4, 2011

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Active fields

ACTIVE COMPARATOR
Device: Resonator device

Inactive device

SHAM COMPARATOR

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

Interventions

Resonator deviceDEVICE

Low level electromagnetic fields for whole body immersion, 3 times weekly for 13 weeks (39) sessions of approximately 11/2 hours each.

Active fields
Resonator device - shamDEVICE

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

Inactive device

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

pico-tesla Magnetic Therapies

Littleton, Colorado, 80120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 23, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations

US(1)