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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04177420
• Other study ID #: B10701016
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: November 2019
• Source: Nanhua University
• Contact: PIN-FAN CHEN, Doctor
• Phone: +886929206688
• Email: pinfan1973[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: February 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• FIR-C mattress
infrared-C irradiation by hot mattress with a powered heating compress
• FIR-C abdominal pad
infrared-C irradiation by hot abdominal pad with a powered heating compress
• fake FIR-C mattress
normal mattress with fake controller, custom make for placebo group
• fake FIR-C abdominal pad
normal abdominal pad with fake controller, custom make for placebo group

Locations

Country	Name	City	State
Taiwan	Department of Natural Biotechnology, Master's program in Natural Healing Sciences Nanhua University	Dalin	Chiayi

Sponsors (3)

Lead Sponsor	Collaborator
Nanhua University	Buddhist Dalin Tzu Chi General Hospital, Solano Semiconductor Technology., LTD.

Country where clinical trial is conducted

Taiwan, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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