Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Evaluation of Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01889784
• Other study ID #: 13573013.1.0000.5504
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: June 7, 2016
• Start date: August 2013
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Universidade Federal de Sao Carlos
• Contact: Cristina O Francisco, Master
• Phone: +55 16 91572798
• Email: cristinaft05[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the phototherapy may be adjuvant to exercise to improve muscular efficiency and increase aerobic capacity. We hypothesized that phototherapy adjuvant with physical exercise may be benefit to populations with Diabetes mellitus that have impairment in cardiopulmonary fitness and low oxygen uptake peak values (VO2peak) in exercise tests. Two doses will be tested 150J and 300J.

Additionally, this study aims to evaluate the effect of phototherapy previously applied to the exercise on the cardiovascular coupling. We hypothesize that phototherapy previously applied to the exercise will result in the increase baroreflex sensitivity (increased coherence and gain and decreased phase), promoting the improvement of the cardiovascular autonomic control and cardiovascular coupling in diabetic subjects. Two doses will be tested 150J and 300J.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• overt coronary disease

• sedentary

• Clinical diagnosis of diabetes mellitus

• Free of diabetes mellitus to participate of control group

Exclusion Criteria:

• autonomic neuropathy

• Smoking

• anemia

• alcoholism

• disability conditions precluding exercise

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Phototherapy through light emitting diode (LED) - 150J
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 40 seconds with 3J of total energy for each diode and 150 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
• Placebo phototherapy - 150J
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 40 seconds with 3J of total energy for each diode and 150 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
• Phototherapy through light emitting diode (LED) - 300J
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 80 seconds with 6J of total energy for each diode and 300 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
• Placebo phototherapy - 300J
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 80 seconds with 6J of total energy for each diode and 300 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Aparecida Maria Catai	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Bauer TA, Reusch JE, Levi M, Regensteiner JG. Skeletal muscle deoxygenation after the onset of moderate exercise suggests slowed microvascular blood flow kinetics in type 2 diabetes. Diabetes Care. 2007 Nov;30(11):2880-5. Epub 2007 Aug 3. — View Citation

Ihsan FR. Low-level laser therapy accelerates collateral circulation and enhances microcirculation. Photomed Laser Surg. 2005 Jun;23(3):289-94. — View Citation

Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810. — View Citation

Leal Junior EC, Lopes-Martins RA, Vanin AA, Baroni BM, Grosselli D, De Marchi T, Iversen VV, Bjordal JM. Effect of 830 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in humans. Lasers Med Sci. 2009 May;24(3):425-31. doi: 10.1007/s10103-008-0592-9. Epub 2008 Jul 23. — View Citation

Paolillo FR, Milan JC, Aniceto IV, Barreto SG, Rebelatto JR, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Effects of infrared-LED illumination applied during high-intensity treadmill training in postmenopausal women. Photomed Laser Surg. 2011 Sep;29(9):639-45. doi: 10.1089/pho.2010.2961. Epub 2011 Jul 12. — View Citation

Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26. — View Citation

Vladimirov YA, Osipov AN, Klebanov GI. Photobiological principles of therapeutic applications of laser radiation. Biochemistry (Mosc). 2004 Jan;69(1):81-90. Review. — View Citation

Wilkerson DP, Poole DC, Jones AM, Fulford J, Mawson DM, Ball CI, Shore AC. Older type 2 diabetic males do not exhibit abnormal pulmonary oxygen uptake and muscle oxygen utilization dynamics during submaximal cycling exercise. Am J Physiol Regul Integr Comp Physiol. 2011 Mar;300(3):R685-92. doi: 10.1152/ajpregu.00479.2010. Epub 2010 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in arterial blood pressure evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)	Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Other	Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in arterial blood pressure evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)	Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Other	Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in glucose and lactate concentrations. Blood samples will be collected by puncturing ear lobe before and 10 minutes after each exercise test had been concluded and will be processed with glucose and lactate analyser (YSI 2300 STAT PLUS - Yellow Springs Instruments - Yellow Springs, USA)	Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Other	Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in glucose and lactate concentrations. Blood samples will be collected by puncturing ear lobe before and 10 minutes after each exercise test had been concluded and will be processed with glucose and lactate analyser (YSI 2300 STAT PLUS - Yellow Springs Instruments - Yellow Springs, USA)	Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Other	Change in heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in heart rate evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)	Change in heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Other	Change in heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in heart rate evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)	Change in heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Primary	Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in muscle oxygen uptake evaluated through near-infrared spectroscopy (NIRS) (Oxymon system, Artinis Medical Systems, Netherlands). The optode of NIRS will be fixed on quadriceps muscle in the right side.	Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Primary	Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J	20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in muscle oxygen uptake evaluated through near-infrared spectroscopy (NIRS) (Oxymon system, Artinis Medical Systems, Netherlands). The optode of NIRS will be fixed on quadriceps muscle in the right side.	Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Secondary	Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J	20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in pulmonary oxygen uptake evaluated through metabolic unit (CPX/D, MedGraphics, St. Paul, Minnesota, USA) continuously collected breath-by-breath.	Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Secondary	Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J	20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in pulmonary oxygen uptake evaluated through metabolic unit (CPX/D, MedGraphics, St. Paul, Minnesota, USA) continuously collected breath-by-breath.	Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Secondary	Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J	20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in baroreflex sensitivity evaluated through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands).	Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No
Secondary	Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J	20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in baroreflex sensitivity evaluated through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands).	Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks	No