Back to resultsInvestigation for Health Efficacy of Infrared-C Radiation on Diabetes Patients in Senior's Activity Center
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
FIR-C mattress
FIR-C abdominal pad
fake FIR-C mattress
fake FIR-C abdominal pad
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring 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
Eligibility 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.
Sites / Locations
- Department of Natural Biotechnology, Master's program in Natural Healing Sciences Nanhua UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experiment Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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
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.
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.
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.
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)
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)
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)
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)
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)
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)
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)
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04177420
First Posted
June 8, 2019
Last Updated
November 22, 2019
Sponsor
Nanhua University
Collaborators
Buddhist Dalin Tzu Chi General Hospital, Solano Semiconductor Technology., LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04177420
Brief Title
Investigation for Health Efficacy of Infrared-C Radiation on Diabetes Patients in Senior's Activity Center
Official Title
Investigation for Health Efficacy of Infrared-C Radiation on Diabetes Patients in Senior's Activity Center
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
February 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanhua University
Collaborators
Buddhist Dalin Tzu Chi General Hospital, Solano Semiconductor Technology., LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FIR-C mattress
Intervention Description
infrared-C irradiation by hot mattress with a powered heating compress
Intervention Type
Device
Intervention Name(s)
FIR-C abdominal pad
Intervention Description
infrared-C irradiation by hot abdominal pad with a powered heating compress
Intervention Type
Device
Intervention Name(s)
fake FIR-C mattress
Intervention Description
normal mattress with fake controller, custom make for placebo group
Intervention Type
Device
Intervention Name(s)
fake FIR-C abdominal pad
Intervention Description
normal abdominal pad with fake controller, custom make for placebo group
Primary Outcome Measure Information:
Title
Hemoglobin A1c, HbA1c
Description
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.
Time Frame
Baseline to 4 months
Title
Fasting Blood Sugar, GLU-AC
Description
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.
Time Frame
Baseline to 4 months
Title
Insulin
Description
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.
Time Frame
Baseline to 4 months
Title
Superoxide, O2-
Description
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.
Time Frame
Baseline to 4 months
Title
Osteocalcin
Description
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.
Time Frame
Baseline to 4 months
Title
Procollagen-I N-telopeptide, PINP
Description
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.
Time Frame
Baseline to 4 months
Title
C-telopeptide of type I collagen，CTx
Description
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
Time Frame
Baseline to 4 months
Title
Total Antioxidant Capacity, TAC
Description
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
Time Frame
Baseline to 4 months
Title
Advanced glycation end-product，AGEs
Description
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.
Time Frame
Baseline to 4 months
Title
Insulin resistance assessment
Description
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.
Time Frame
Baseline to 4 months
Title
Beta-cell function assessment
Description
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.
Time Frame
Baseline to 4 months
Title
Autonomic nervous system assessment - Heart Rate
Description
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)
Time Frame
Baseline to 4 months
Title
Autonomic nervous system assessment - blood pressure
Description
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)
Time Frame
Baseline to 4 months
Title
Autonomic nervous system assessment - Heart Rate Variability
Description
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)
Time Frame
Baseline to 4 months
Title
Autonomic nervous system assessment - Low Frequency
Description
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)
Time Frame
Baseline to 4 months
Title
Autonomic nervous system assessment - High Frequency
Description
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)
Time Frame
Baseline to 4 months
Title
Autonomic nervous system assessment - Low/High Frequency standard
Description
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)
Time Frame
Baseline to 4 months
Title
Autonomic nervous system assessment - Irregular Heartbeat standard
Description
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)
Time Frame
Baseline to 4 months
Title
Pittsburgh sleep quality index (PSQI)
Description
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.
Time Frame
Baseline to 4 months
Title
Knee Pain - Numeric Rating Scale, Knee Pain - NRS
Description
To measure the Knee's painfulness. The higher of the score means the knee's more painful.
Time Frame
Baseline to 4 months
Title
Geriatric Depression Scale-15, GDS-15
Description
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
Time Frame
Baseline to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PIN-FAN CHEN, Doctor
Phone
+886929206688
Email
pinfan1973@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Chih Lin, Professor
Phone
+886972019645
Email
benjasado@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching Yong Chin, Master
Organizational Affiliation
Nanhua University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi-Wen Huang, Master
Organizational Affiliation
Nanhua University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin-Bang Shang, Master
Organizational Affiliation
Nanhua University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Natural Biotechnology, Master's program in Natural Healing Sciences Nanhua University
City
Dalin
State/Province
Chiayi
ZIP/Postal Code
62249
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YA YUN JUANG
Phone
+88652721001
Ext
2641
Email
minie0126@nhu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigation for Health Efficacy of Infrared-C Radiation on Diabetes Patients in Senior's Activity Center
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