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

NCT04177420 | Unknown

• 1 other identifier: B10701016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (21)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Experiment Group

EXPERIMENTAL

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.

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

Control Group

PLACEBO COMPARATOR

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.

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

Interventions

FIR-C mattress DEVICE

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

Experiment Group

FIR-C abdominal pad DEVICE

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

Experiment Group

fake FIR-C mattress DEVICE

normal mattress with fake controller, custom make for placebo group

Control Group

fake FIR-C abdominal pad DEVICE

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

Control Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanhua University: lead
• Buddhist Dalin Tzu Chi General Hospital: collaborator
• Solano Semiconductor Technology., LTD.: collaborator

Study Sites (1)

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

Dalin, Chiayi, 62249, Taiwan

RECRUITING

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Xanthomatosis, Cerebrotendinous; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Xanthomatosis

Study Officials

• Ching Yong Chin, Master

  Nanhua University

  PRINCIPAL INVESTIGATOR

• Yi-Wen Huang, Master

  Nanhua University

  PRINCIPAL INVESTIGATOR

• Jin-Bang Shang, Master

  Nanhua University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PIN-FAN CHEN, Doctor

CONTACT

+886929206688; pinfan1973@gmail.com

Chun-Chih Lin, Professor

CONTACT

+886972019645; benjasado@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2019
• First Posted: November 26, 2019
• Study Start: March 23, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 15, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)