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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Universidade Federal de Sao Carlos
Sponsor:
Information provided by (Responsible Party):
Aparecida Maria Catai, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01889784
First received: June 5, 2013
Last updated: August 20, 2014
Last verified: August 2014

June 5, 2013
August 20, 2014
August 2013
August 2014   (final data collection date for primary outcome measure)
Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) [ Time Frame: Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 60 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 5 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.
Same as current
Complete list of historical versions of study NCT01889784 on ClinicalTrials.gov Archive Site
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) [ Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 60 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 5 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.
Same as current
  • Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) [ Time Frame: Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
    20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 60 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 5 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 glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) [ Time Frame: Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
    20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 60 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 5 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 5 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 heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) [ Time Frame: Change in heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
    20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 60 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 5 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 arterial blood pressure and heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) [ Time Frame: Change in arterial blood pressure and heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
    20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 60 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 5 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in arterial blood pressure and heart rate evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)
  • Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) [ Time Frame: Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
    20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 60 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 5 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 5 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)
 
Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus
Evaluation of Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption in Patients With Diabetes Mellitus

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Device: Phototherapy through light emitting diode (LED)
    The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode 157 arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm, class 2M 158 LED). The phototherapy will be applied bilaterally on femoral quadriceps muscle during 60 seconds with 3J of total energy. 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.
  • Device: Placebo phototherapy
    The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode 157 arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm, class 2M 158 LED). The phototherapy will be applied bilaterally on femoral quadriceps muscle during 60 seconds with 3J of total energy. 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.
  • Individuals with diabetes mellitus
    The intervention of this study is phototherapy through light emitting diode (LED). The Effective-LED or Placebo-LED will be applied in femoral quadriceps muscle bilaterally 5 minutes 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.
    Interventions:
    • Device: Phototherapy through light emitting diode (LED)
    • Device: Placebo phototherapy
  • Active Comparator: Health individuals
    The intervention of this study is phototherapy through light emitting diode (LED). The Effective-LED or Placebo-LED will be applied in femoral quadriceps muscle bilaterally 5 minutes 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.
    Interventions:
    • Device: Phototherapy through light emitting diode (LED)
    • Device: Placebo phototherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2015
August 2014   (final data collection date for primary outcome measure)

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
Male
45 Years to 65 Years
Yes
Contact: Cristina O Francisco, Master +55 16 91572798 cristinaft05@gmail.com
Contact: Amanda Shimojo, Physiotherapist +55 16 33518705
Brazil
 
NCT01889784
13573013.1.0000.5504
No
Aparecida Maria Catai, Universidade Federal de Sao Carlos
Aparecida Maria Catai
Not Provided
Principal Investigator: Aparecida M Catai, pHD Universidade Federal de Sao Carlos
Universidade Federal de Sao Carlos
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP