Diabetes Mellitus, Type 2
Conditions
Keywords
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
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.
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.
Interventions
DEVICEFIR-C mattress
infrared-C irradiation by hot mattress with a powered heating compress
DEVICEFIR-C abdominal pad
infrared-C irradiation by hot abdominal pad with a powered heating compress
DEVICEfake FIR-C mattress
normal mattress with fake controller, custom make for placebo group
DEVICEfake FIR-C abdominal pad
normal abdominal pad with fake controller, custom make for placebo group
Sponsors
Buddhist Dalin Tzu Chi General Hospital
Solano Semiconductor Technology., LTD.
Nanhua University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c, HbA1c | 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. |
| Fasting Blood Sugar, GLU-AC | 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. |
| Insulin | 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. |
| Superoxide, O2- | 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. |
| Osteocalcin | 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. |
| Procollagen-I N-telopeptide, PINP | 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. |
| C-telopeptide of type I collagen，CTx | 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 |
| Total Antioxidant Capacity, TAC | 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 |
| Advanced glycation end-product，AGEs | 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. |
| Insulin resistance assessment | 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. |
| Beta-cell function assessment | 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. |
| Autonomic nervous system assessment - Heart Rate | 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) |
| Autonomic nervous system assessment - blood pressure | 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) |
| Autonomic nervous system assessment - Heart Rate Variability | 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) |
| Autonomic nervous system assessment - Low Frequency | 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) |
| Autonomic nervous system assessment - High Frequency | 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) |
| Autonomic nervous system assessment - Low/High Frequency standard | 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) |
| Autonomic nervous system assessment - Irregular Heartbeat standard | 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) |
| Pittsburgh sleep quality index (PSQI) | 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. |
| Knee Pain - Numeric Rating Scale, Knee Pain - NRS | Baseline to 4 months | To measure the Knee's painfulness. The higher of the score means the knee's more painful. |
| Geriatric Depression Scale-15, GDS-15 | 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 |
Countries
Taiwan
Contacts
Primary ContactPIN-FAN CHEN, Doctor
Backup ContactChun-Chih Lin, Professor
Outcome results
None listed