Clinical trial NCT04177420: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Nanhua University
Sponsor class: OTHER
Collaborators: name: Buddhist Dalin Tzu Chi General Hospital
name: Solano Semiconductor Technology., LTD.
First posted: 2019-11-26
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Hemoglobin A1c, HbA1c
timeFrame: Baseline to 4 months
measure: Fasting Blood Sugar, GLU-AC
timeFrame: Baseline to 4 months
measure: Insulin
timeFrame: Baseline to 4 months
measure: Superoxide, O2-
timeFrame: Baseline to 4 months
measure: Osteocalcin
timeFrame: Baseline to 4 months
measure: Procollagen-I N-telopeptide, PINP
timeFrame: Baseline to 4 months
measure: C-telopeptide of type I collagen，CTx
timeFrame: Baseline to 4 months
measure: Total Antioxidant Capacity, TAC
timeFrame: Baseline to 4 months
measure: Advanced glycation end-product，AGEs
timeFrame: Baseline to 4 months
measure: Insulin resistance assessment
timeFrame: Baseline to 4 months
measure: Beta-cell function assessment
timeFrame: Baseline to 4 months
measure: Autonomic nervous system assessment - Heart Rate
timeFrame: Baseline to 4 months
measure: Autonomic nervous system assessment - blood pressure
timeFrame: Baseline to 4 months
measure: Autonomic nervous system assessment - Heart Rate Variability
timeFrame: Baseline to 4 months
measure: Autonomic nervous system assessment - Low Frequency
timeFrame: Baseline to 4 months
measure: Autonomic nervous system assessment - High Frequency
timeFrame: Baseline to 4 months
measure: Autonomic nervous system assessment - Low/High Frequency standard
timeFrame: Baseline to 4 months
measure: Autonomic nervous system assessment - Irregular Heartbeat standard
timeFrame: Baseline to 4 months
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline to 4 months
measure: Knee Pain - Numeric Rating Scale, Knee Pain - NRS
timeFrame: Baseline to 4 months
measure: Geriatric Depression Scale-15, GDS-15
timeFrame: Baseline to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dalin
country: Taiwan
facility: Department of Natural Biotechnology, Master's program in Natural Healing Sciences Nanhua University
state: Chiayi
Study officials:
affiliation: Nanhua University
name: Ching Yong Chin, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanhua University
name: Yi-Wen Huang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanhua University
name: Jin-Bang Shang, Master
role: PRINCIPAL_INVESTIGATOR
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