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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Phototherapy through light emitting diode (LED) - 150J
* Device: Placebo phototherapy - 150J
* Device: Phototherapy through light emitting diode (LED) - 300J
* Device: Placebo phototherapy - 300J


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Individuals with diabetes mellitus (phototherapy 150J)<br>The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy. | Device: Phototherapy through light emitting diode (LED) - 150J<br>* 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.<br>Device: Placebo phototherapy - 150J<br>* 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.<br>|
| Other: Health individuals - 150J (phototherapy 150J)<br>The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy. | Device: Phototherapy through light emitting diode (LED) - 150J<br>* 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.<br>Device: Placebo phototherapy - 150J<br>* 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.<br>|
| Other: Individuals with diabetes mellitus (phototherapy 300J)<br>The intervention of this study is phototherapy through light emitting diode (LED) with 300J. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surale muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy. | Device: Phototherapy through light emitting diode (LED) - 300J<br>* 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.<br>Device: Placebo phototherapy - 300J<br>* 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.<br>|
| Other: Health individuals (phototherapy 300J)<br>The intervention of this study is phototherapy through light emitting diode (LED). The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy. | Device: Phototherapy through light emitting diode (LED) - 300J<br>* 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.<br>Device: Placebo phototherapy - 300J<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, type 2, phototherapy, physical exercise, oxygen consumption, arterial blood pressure, heart rate, baroreflex sensitivity, cardiovascular autonomic control