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

Nanhua University

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: FIR-C mattress; Device: FIR-C abdominal pad; Device: fake FIR-C abdominal pad; Device: fake FIR-C mattress

Study type: Interventional

Funder types: Other

Identifiers

NCT04177420

B10701016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

Experiment Group

Experimental group

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.

Treatment:

Device: FIR-C mattress

Device: FIR-C abdominal pad

Control Group

Placebo Comparator group

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.

Treatment:

Device: fake FIR-C abdominal pad

Device: fake FIR-C mattress