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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 12, 2007 | ||||||||
| Last Updated Date | August 14, 2009 | ||||||||
| Start Date ICMJE | May 2006 | ||||||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary end point is to determine the therapeutic effects of far infrared radiation on all types of diabetes. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00573456 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diabetes Mellitus | ||||||||
| Intervention ICMJE | Radiation: Far Infrared Radiation
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes per session. |
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| Study Arms / Comparison Groups | 1
Intervention: Radiation: Far Infrared Radiation |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 2 | ||||||||
| Estimated Completion Date | April 2009 | ||||||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00573456 | ||||||||
| Responsible Party | Dr. Kwasi Donyina/Founder & President, GAAD Medical Research Institute Inc. | ||||||||
| Study ID Numbers ICMJE | GAAD-DM-CTP1 | ||||||||
| Study Sponsor ICMJE | GAAD Medical Research Institute Inc. | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | GAAD Medical Research Institute Inc. | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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