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Diabetes Mellitus, Type 2NCT04177420

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

A study testing FIR-C mattress, FIR-C abdominal pad and fake FIR-C mattress in people with Diabetes Mellitus, Type 2, run by Nanhua University at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
FIR-C mattress, FIR-C abdominal pad and fake FIR-C mattress
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteTaiwan
Study dates
23 Mar 2018to 15 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

PIN-FAN CHEN, Doctor contact

+886929206688

pinfan1973@gmail.com

Chun-Chih Lin, Professor contact

+886972019645

benjasado@gmail.com

Taiwan1 site, 1 recruiting

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

    Dalin, Chiayi, 62249

    YA YUN JUANG, +88652721001 ext. 2641, minie0126@nhu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
FIR-C mattress, FIR-C abdominal pad, fake FIR-C mattress, fake FIR-C abdominal pad
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
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance, Xanthomatosis, Cerebrotendinous, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FIR-C mattressDevice

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

  • FIR-C abdominal padDevice

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

  • fake FIR-C mattressDevice

    normal mattress with fake controller, custom make for placebo group

  • fake FIR-C abdominal padDevice

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

Study groups in NCT04177420
Study groupRoleWhat they receive
Experiment GroupExperimentallay 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.
Receives: Device: FIR-C mattress; Device: FIR-C abdominal pad
Control GroupPlacebo comparatorlay 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.
Receives: Device: fake FIR-C mattress; Device: fake FIR-C abdominal pad

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 4 months

  2. 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.

    Measured: Baseline to 4 months

  3. 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.

    Measured: Baseline to 4 months

  4. 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.

    Measured: Baseline to 4 months

  5. 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.

    Measured: Baseline to 4 months

  6. 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.

    Measured: Baseline to 4 months

  7. 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

    Measured: Baseline to 4 months

  8. 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

    Measured: Baseline to 4 months

  9. 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.

    Measured: Baseline to 4 months

  10. 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.

    Measured: Baseline to 4 months

  11. 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.

    Measured: Baseline to 4 months

  12. 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)

    Measured: Baseline to 4 months

  13. 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)

    Measured: Baseline to 4 months

  14. 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)

    Measured: Baseline to 4 months

  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)

    Measured: Baseline to 4 months

  16. 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)

    Measured: Baseline to 4 months

  17. 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)

    Measured: Baseline to 4 months

  18. 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)

    Measured: Baseline to 4 months

  19. 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.

    Measured: Baseline to 4 months

  20. 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.

    Measured: Baseline to 4 months

  21. 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

    Measured: Baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start23 Mar 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion15 Feb 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04177420
Sponsor's protocol ID
B10701016
Status last verified
Nov 2019
First submitted
8 Jun 2019
Last updated
26 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cegrell L. The occurrence of biogenic monoamines in the mammalian endocrine pancreas. Acta Physiol Scand Suppl. 1968;314:1-60. No abstract available.

    PubMed 4973243

  • Chang Y, Liu YP, Liu CF. The effect on serotonin and MDA levels in depressed patients with insomnia when far-infrared rays are applied to acupoints. Am J Chin Med. 2009;37(5):837-42. doi: 10.1142/S0192415X09007272.

    PubMed 19885944

  • COUPLAND RE. The innervation of pan creas of the rat, cat and rabbit as revealed by the cholinesterase technique. J Anat. 1958 Jan;92(1):143-9. No abstract available.

    PubMed 13513506

  • Dandona P, Aljada A, Bandyopadhyay A. Inflammation: the link between insulin resistance, obesity and diabetes. Trends Immunol. 2004 Jan;25(1):4-7. doi: 10.1016/j.it.2003.10.013.

    PubMed 14698276

  • Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.

    PubMed 21030723

  • Haag M, Dippenaar NG. Dietary fats, fatty acids and insulin resistance: short review of a multifaceted connection. Med Sci Monit. 2005 Dec;11(12):RA359-67. Epub 2005 Nov 24.

    PubMed 16319806

  • Haffner SM, Kennedy E, Gonzalez C, Stern MP, Miettinen H. A prospective analysis of the HOMA model. The Mexico City Diabetes Study. Diabetes Care. 1996 Oct;19(10):1138-41. doi: 10.2337/diacare.19.10.1138.

    PubMed 8886564

  • Honda K, Inoue S. Sleep-enhancing effects of far-infrared radiation in rats. Int J Biometeorol. 1988 Jun;32(2):92-4. doi: 10.1007/BF01044900. No abstract available.

    PubMed 3410585

  • Benzie IF, Strain JJ. The ferric reducing ability of plasma (FRAP) as a measure of "antioxidant power": the FRAP assay. Anal Biochem. 1996 Jul 15;239(1):70-6. doi: 10.1006/abio.1996.0292.

    PubMed 8660627

  • Lu FJ, Lin JT, Wang HP, Huang WC. A simple, sensitive, non-stimulated photon counting system for detection of superoxide anion in whole blood. Experientia. 1996 Feb 15;52(2):141-4. doi: 10.1007/BF01923359.

    PubMed 8608815

  • Ishibashi J, Yamashita K, Ishikawa T, Hosokawa H, Sumida K, Nagayama M, Kitamura S. The effects inhibiting the proliferation of cancer cells by far-infrared radiation (FIR) are controlled by the basal expression level of heat shock protein (HSP) 70A. Med Oncol. 2008;25(2):229-37. doi: 10.1007/s12032-007-9020-4. Epub 2007 Oct 30.

    PubMed 17968683

  • Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. doi: 10.1038/nature05482.

    PubMed 17167471

  • Kasznicki J, Kosmalski M, Sliwinska A, Mrowicka M, Stanczyk M, Majsterek I, Drzewoski J. Evaluation of oxidative stress markers in pathogenesis of diabetic neuropathy. Mol Biol Rep. 2012 Sep;39(9):8669-78. doi: 10.1007/s11033-012-1722-9. Epub 2012 Jun 21.

    PubMed 22718504

  • Lin CC, Chiang YS, Lung CC. Effect of infrared-C radiation on skin temperature, electrodermal conductance and pain in hemiparetic stroke patients. Int J Radiat Biol. 2015 Jan;91(1):42-53. doi: 10.3109/09553002.2014.937512. Epub 2014 Aug 11.

    PubMed 24991883

  • Maritim AC, Sanders RA, Watkins JB 3rd. Diabetes, oxidative stress, and antioxidants: a review. J Biochem Mol Toxicol. 2003;17(1):24-38. doi: 10.1002/jbt.10058.

    PubMed 12616644

Questions about this trial

What is this clinical trial studying?

A study testing FIR-C mattress, FIR-C abdominal pad and fake FIR-C mattress in people with Diabetes Mellitus, Type 2, run by Nanhua University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact PIN-FAN CHEN, Doctor (+886929206688, pinfan1973@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c, HbA1c (time frame: Baseline to 4 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04177420, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.

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