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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: FIR-C mattress
* Device: FIR-C abdominal pad
* Device: fake FIR-C mattress
* Device: fake FIR-C abdominal pad


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment Group<br>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<br>* infrared-C irradiation by hot mattress with a powered heating compress<br>Device: FIR-C abdominal pad<br>* infrared-C irradiation by hot abdominal pad with a powered heating compress<br>|
| Placebo Comparator: Control Group<br>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<br>* normal mattress with fake controller, custom make for placebo group<br>Device: fake FIR-C abdominal pad<br>* normal abdominal pad with fake controller, custom make for placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c, HbA1c | 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. | Baseline to 4 months | 
| Fasting Blood Sugar, GLU-AC | 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. | Baseline to 4 months | 
| Insulin | 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. | Baseline to 4 months | 
| Superoxide, O2- | 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. | Baseline to 4 months | 
| Osteocalcin | 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. | Baseline to 4 months | 
| Procollagen-I N-telopeptide, PINP | 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. | Baseline to 4 months | 
| C-telopeptide of type I collagen，CTx | 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 | Baseline to 4 months | 
| Total Antioxidant Capacity, TAC | 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 | Baseline to 4 months | 
| Advanced glycation end-product，AGEs | 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. | Baseline to 4 months | 
| Insulin resistance assessment | 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. | Baseline to 4 months | 
| Beta-cell function assessment | 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. | Baseline to 4 months | 
| Autonomic nervous system assessment - Heart Rate | 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) | Baseline to 4 months | 
| Autonomic nervous system assessment - blood pressure | 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) | Baseline to 4 months | 
| Autonomic nervous system assessment - Heart Rate Variability | 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) | Baseline to 4 months | 
| Autonomic nervous system assessment - Low Frequency | 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) | Baseline to 4 months | 
| Autonomic nervous system assessment - High Frequency | 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) | Baseline to 4 months | 
| Autonomic nervous system assessment - Low/High Frequency standard | 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) | Baseline to 4 months | 
| Autonomic nervous system assessment - Irregular Heartbeat standard | 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) | Baseline to 4 months | 
| Pittsburgh sleep quality index (PSQI) | 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. | Baseline to 4 months | 
| Knee Pain - Numeric Rating Scale, Knee Pain - NRS | To measure the Knee's painfulness. The higher of the score means the knee's more painful. | Baseline to 4 months | 
| Geriatric Depression Scale-15, GDS-15 | 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 | Baseline to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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