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

NCT ID: NCT04177420

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2020-02-15

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experiment Group

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.

Group Type EXPERIMENTAL

FIR-C mattress

Intervention Type DEVICE

infrared-C irradiation by hot mattress with a powered heating compress

FIR-C abdominal pad

Intervention Type DEVICE

infrared-C irradiation by hot abdominal pad with a powered heating compress

Control Group

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.

Group Type PLACEBO_COMPARATOR

fake FIR-C mattress

Intervention Type DEVICE

normal mattress with fake controller, custom make for placebo group

fake FIR-C abdominal pad

Intervention Type DEVICE

normal abdominal pad with fake controller, custom make for placebo group

Interventions

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FIR-C mattress

infrared-C irradiation by hot mattress with a powered heating compress

Intervention Type DEVICE

FIR-C abdominal pad

infrared-C irradiation by hot abdominal pad with a powered heating compress

Intervention Type DEVICE

fake FIR-C mattress

normal mattress with fake controller, custom make for placebo group

Intervention Type DEVICE

fake FIR-C abdominal pad

normal abdominal pad with fake controller, custom make for placebo group

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buddhist Dalin Tzu Chi General Hospital

UNKNOWN

Sponsor Role collaborator

Solano Semiconductor Technology., LTD.

UNKNOWN

Sponsor Role collaborator

Nanhua University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching Yong Chin, Master

Role: PRINCIPAL_INVESTIGATOR

Nanhua University

Yi-Wen Huang, Master

Role: PRINCIPAL_INVESTIGATOR

Nanhua University

Jin-Bang Shang, Master

Role: PRINCIPAL_INVESTIGATOR

Nanhua University

Locations

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Department of Natural Biotechnology, Master's program in Natural Healing Sciences Nanhua University

Dalin, Chiayi, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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PIN-FAN CHEN, Doctor

Role: CONTACT

+886929206688

Chun-Chih Lin, Professor

Role: CONTACT

+886972019645

Facility Contacts

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YA YUN JUANG

Role: primary

+88652721001 ext. 2641

References

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Other Identifiers

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B10701016

Identifier Type: -

Identifier Source: org_study_id

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