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Investigation for Health Efficacy of Infrared-C Radiation on Diabetes Patients in Senior's Activity Center

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ClinicalTrials.gov Identifier: NCT04177420
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborators:
Buddhist Dalin Tzu Chi General Hospital
Solano Semiconductor Technology., LTD.
Information provided by (Responsible Party):
Nanhua University

Brief Summary:
Hyperglycemia caused by diabetes will bring us the long-term damage,it causes glycation. The combination of sugar molecules and protein molecules will transform to advanced glycation end products (AGEs) and produce a lot of free radicals to caused inflammatory reactions, forming various comorbidities, affecting the function of different organs, especially the eyes, kidneys, nervous system, heart, blood vessels and damage to bone structure and bone Quality, which leads to bone loss. Therefore, the development of alternative therapies is important for the treatment of diabetes. We assume the 4 months experiment can normalize subjects HbA1c.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: FIR-C mattress Device: FIR-C abdominal pad Device: fake FIR-C mattress Device: fake FIR-C abdominal pad Not Applicable

Detailed Description:
In the past research from our team, it was found that far infrared ray (FIR) helps to reduce oxidative stress in the body and is expected to contribute to the treatment of diabetes. Therefore, the team hopes to effectively reduce glycated hemoglobin (HbA1c), fasting blood glucose (GLU-AC), insulin (insulin), reduce the body's oxidative stress index, increase Total Antioxidant Capacity (TAC) inhibit the inflammatory response and reduce complications through 4 months of IR-C intervention. Which expected to reduce the index of the nitrogen-type first collagen element (Procollagen-I N -telopeptide, PINP) and C-telopeptide of type I collagen (CTx) bone loss index, enhance Osteocalcin's index of bone growth indicators. Along with the Pittsburgh sleep quality index (PSQI), numeric rating scale-knee (NRS-knee) and Geriatric depression Scale-15 (GDS-15) to reduce the number of times the elderly take medication and improve their health and quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Investigation for Health Efficacy of Infrared-C Radiation on Diabetes Patients in Senior's Activity Center
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 15, 2020

Arm Intervention/treatment
Experimental: Experiment Group
lay on the FIR-C mattress with cover the FIR-C abdominal pad on abdominal part and Knee part during the sleeping time. The controller will switch on and switch off rotated in each hour for whole night.
Device: FIR-C mattress
infrared-C irradiation by hot mattress with a powered heating compress

Device: FIR-C abdominal pad
infrared-C irradiation by hot abdominal pad with a powered heating compress

Placebo Comparator: Control Group
lay on the FIR-C mattress with cover the FIR-C abdominal pad on abdominal part and Knee part during the sleeping time. The controller will switch on and switch off rotated in each hour for whole night. the FIR-C mattress and the FIR-C abdominal pad is malfunction and it can not produce the FIR-C.
Device: fake FIR-C mattress
normal mattress with fake controller, custom make for placebo group

Device: fake FIR-C abdominal pad
normal abdominal pad with fake controller, custom make for placebo group




Primary Outcome Measures :
  1. Hemoglobin A1c, HbA1c [ Time Frame: Baseline to 4 months ]
    The hemoglobin A1c can show us our average level of blood sugar over the past 2 to 3 months. Below 6% is normal, over 6% is abnormal.

  2. Fasting Blood Sugar, GLU-AC [ Time Frame: Baseline to 4 months ]
    A blood sample will be taken after an overnight fast which to estimate blood sugar levels. Below 100mg/dL is normal, 100 to 125mg/dL is prediabetes, 125mg/dL above is consider diabetes.

  3. Insulin [ Time Frame: Baseline to 4 months ]
    Is a hormone that is produced and stored in the beta cells of the pancreas. this test can measures the amount of insulin in the blood which to analyze the insulin resistance of the body.

  4. Superoxide, O2− [ Time Frame: Baseline to 4 months ]
    superoxide is one type of the free radical. The assay of superoxide can show us the ability to inhibit free radical contained in blood. The highest value of it means the highest injured did. The data of the post-test should be lower than the data of the pre-test.

  5. Osteocalcin [ Time Frame: Baseline to 4 months ]
    Is a noncollagenous protein hormone found in bone and dentin, it implicated in bone mineralization and calcium ion homeostasis. The normal range for female: 12-23ng/dL; the normal range for male: 17-26ng/dL.

  6. Procollagen-I N-telopeptide, PINP [ Time Frame: Baseline to 4 months ]
    This market is a specific indicator of type I collagen deposition therefore can set as an indicator of bone formation velocity. The reference's range for PINP: 16.27 - 73.87 ng/mL.

  7. C-telopeptide of type I collagen,CTx [ Time Frame: Baseline to 4 months ]
    It is the carbon-terminal fragment of the first type of collagen in the bone, which is the final product of bone decomposition and can be used as an indicator of bone loss. The reference's range for female: 0.104-1.008ng/mL; for male: 0.000-0.854ng/mL

  8. Total Antioxidant Capacity, TAC [ Time Frame: Baseline to 4 months ]
    to assess the antioxidant status of blood to evaluate the antioxidant response against the free radicals produced in the blood. The reference's range for male: >=0.65mmol/L; female: >=0.54mmol/L

  9. Advanced glycation end-product,AGEs [ Time Frame: Baseline to 4 months ]
    AGEs are proteins or lipids that become glycated as a result of exposure to sugars. Its can be a factor in aging and in the development from diabetes. The highest value of it means the highest injured did. The data of the post-test should be lower than the data of the pre-test.

  10. Insulin resistance assessment [ Time Frame: Baseline to 4 months ]
    to measure the insulin sensitivity of the cells, the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) method will be applied in this study. The highest value of it means the highest injured did. The data of the post-test should be lower than the data of the pre-test.

  11. Beta-cell function assessment [ Time Frame: Baseline to 4 months ]
    to measure the function of the Beta-cell, the HOMA-beta-cell method will be applied in this study. The highest value of it means the function of the Beta-cell more normal. The data of the post-test should be higher than the data of the pre-test.

  12. Autonomic nervous system assessment - Heart Rate [ Time Frame: Baseline to 4 months ]

    the measurement of Autonomic nervous system assessment is to measure the functions of sympathetic and the parasympathetic. The scale of this assessment is HR(Heart Rate).

    HR(1/min):normal range(60-100),abnormal range(lower than 60 or higher than 100)


  13. Autonomic nervous system assessment - blood pressure [ Time Frame: Baseline to 4 months ]

    the measurement of Autonomic nervous system assessment is to measure the functions of sympathetic and the parasympathetic. The scale of this assessment is about blood pressure.

    SYS(mmHg):normal range(90-140), abnormal range(higher than 140) DIA(mmHg):normal range(60-90), abnormal range(higher than 90) SYS(mmHg) and DIA(mmHg) will be combined to report blood pressure in SYS/DIA(mmHg)


  14. Autonomic nervous system assessment - Heart Rate Variability [ Time Frame: Baseline to 4 months ]

    the measurement of Autonomic nervous system assessment is to measure the functions of sympathetic and the parasympathetic. The scale of this assessment is about HRV(Heart Rate Variability).

    HRV(ms): normal range(25-100), abnormal range(lower than 15)


  15. Autonomic nervous system assessment - Low Frequency [ Time Frame: Baseline to 4 months ]

    the measurement of Autonomic nervous system assessment is to measure the functions of sympathetic and the parasympathetic. The scale of this assessment is about LF(Low Frequency %).

    LF(%): normal range(40-70), abnormal range(higher than 80)


  16. Autonomic nervous system assessment - High Frequency [ Time Frame: Baseline to 4 months ]

    the measurement of Autonomic nervous system assessment is to measure the functions of sympathetic and the parasympathetic. The scale of this assessment is about HF(High Frequency %).

    HF(%): normal range(25-40), abnormal range(lower than 20)


  17. Autonomic nervous system assessment - Low/High Frequency standard [ Time Frame: Baseline to 4 months ]

    the measurement of Autonomic nervous system assessment is to measure the functions of sympathetic and the parasympathetic. The scale of this assessment is about LF/HF(Low/High Frequency standard).

    LF/HF: normal range(0.5-2.5), abnormal range(higher than 3)


  18. Autonomic nervous system assessment - Irregular Heartbeat standard [ Time Frame: Baseline to 4 months ]

    the measurement of Autonomic nervous system assessment is to measure the functions of sympathetic and the parasympathetic. The scale of this assessment is about IR(Irregular Heartbeat standard).

    IR: normal range(0-3), abnormal range(higher than 4)


  19. Pittsburgh sleep quality index (PSQI) [ Time Frame: Baseline to 4 months ]
    The PSQI is a questionnaire to measure sleep quality over the past month. the 19 items question can be grouped into 7 components, its (1)sleep duration; (2) sleep disturbance;(3) sleep latency; (4) daytime dysfunction due to sleepiness; (5) sleep efficiency; (6) overall sleep quality; (7) sleep medication use. The sleep component scores are summed to a total score ranging from 0 to 21. The higher of the total score means the sleep quality worse.

  20. Knee Pain - Numeric Rating Scale, Knee Pain - NRS [ Time Frame: Baseline to 4 months ]
    To measure the Knee's painfulness. The higher of the score means the knee's more painful.

  21. Geriatric Depression Scale-15, GDS-15 [ Time Frame: Baseline to 4 months ]

    to assess depressive symptoms among old people with differing level of cognitive function.

    1-5 : healthy 6-9 : light depression 10 and above : serious depression




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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1c higher than 6.8% or fasting blood sugar higher than 126mg/dL;
  • Conscious, mental and cognitively normal;
  • no obstacles in action;
  • can read, write and communicate with mandarin, taiwanese and hakka.

Exclusion Criteria:

  • Inflammatory skin wounds on the neck, back, lower back or lower leg;
  • obstacles in communication;
  • People with disabilities, epilepsy, and other unacceptable warming treatments;
  • When the subject finds that he or she is unwell during the procedure, the experiment is terminated and take care by the medical staff.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177420


Contacts
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Contact: PIN-FAN CHEN, Doctor +886929206688 pinfan1973@gmail.com
Contact: Chun-Chih Lin, Professor +886972019645 benjasado@gmail.com

Locations
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Taiwan
Department of Natural Biotechnology, Master's program in Natural Healing Sciences Nanhua University Recruiting
Dalin, Chiayi, Taiwan, 62249
Contact: YA YUN JUANG    +88652721001 ext 2641    minie0126@nhu.edu.tw   
Sponsors and Collaborators
Nanhua University
Buddhist Dalin Tzu Chi General Hospital
Solano Semiconductor Technology., LTD.
Investigators
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Principal Investigator: Ching Yong Chin, Master Nanhua University
Principal Investigator: Yi-Wen Huang, Master Nanhua University
Principal Investigator: Jin-Bang Shang, Master Nanhua University

Publications of Results:
Other Publications:

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Responsible Party: Nanhua University
ClinicalTrials.gov Identifier: NCT04177420     History of Changes
Other Study ID Numbers: B10701016
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanhua University:
Types 2 Diabetes Mellitus
Glycation
AGEs
hemoglobin A1c, HbA1c
Fasting blood sugar, GLU-AC
Insulin
Procollagen-I N-telopeptide, PINP
C-telopeptide of type I collagen, CTx
osteocalcin
Pittsburgh sleep quality index, PSQI
numeric rating scale-knee, NRS-knee
Geriatric depression Scale-15, GDS-15
Total Antioxidant Capacity, TAC
Infrared-C
Hyperglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases