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Far Infrared Radiation Treatment for Diabetes

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ClinicalTrials.gov Identifier: NCT00573456
Recruitment Status : Unknown
Verified August 2009 by GAAD Medical Research Institute Inc..
Recruitment status was:  Active, not recruiting
First Posted : December 14, 2007
Last Update Posted : August 17, 2009
Sponsor:
Information provided by:
GAAD Medical Research Institute Inc.

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 14, 2007
Last Update Posted Date August 17, 2009
Study Start Date  ICMJE May 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2007)
The primary end point is to determine the therapeutic effects of far infrared radiation on all types of diabetes. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2007)
The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other types of diabetes complications including blindness, heart and blood vessel disease and kidney failure. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Far Infrared Radiation Treatment for Diabetes
Official Title  ICMJE Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Diabetes
Brief Summary A study to determine the use of far infrared (FIR) radiation for treatment of diabetes.
Detailed Description

Diabetes mellitus is a disease in which glucose is not sufficiently metabolized. This results in high glucose levels in blood and glucose in the urine. Cells can starve because glucose is not being metabolized.

Both types of diabetes can cause dangerous complications, including blindness, heart and blood vessel disease, and kidney failure. A decrease in circulation may eventually require the amputation of limbs.

We are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby improving the health of the patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Radiation: Far Infrared Radiation
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes per session.
Study Arms  ICMJE 1
Intervention: Radiation: Far Infrared Radiation
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: August 14, 2009)
2
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2007)
3
Estimated Study Completion Date  ICMJE April 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Persons with type 1 or type 2 diabetes

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, 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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00573456
Other Study ID Numbers  ICMJE GAAD-DM-CTP1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Kwasi Donyina/Founder & President, GAAD Medical Research Institute Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GAAD Medical Research Institute Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ken Nedd, M.D. GAAD Medical Research Institute Inc.
Study Chair: Kwasi Donyina, Ph.D. GAAD Medical Research Institute Inc.
PRS Account GAAD Medical Research Institute Inc.
Verification Date August 2009

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