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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 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: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Device: Phototherapy through light emitting diode (LED)
Device: Placebo phototherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption in Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889784

Contacts
Contact: Cristina O Francisco, Master +55 16 91572798 cristinaft05@gmail.com
Contact: Amanda Shimojo, Physiotherapist +55 16 33518705

Locations
Brazil
Universidade Federal de São Carlos Not yet recruiting
São Carlos, São Paulo, Brazil, 13565-905
Sub-Investigator: Cristina O Francisco, doctorate in progress         
Principal Investigator: Aparecida M Catai, pHD         
Sponsors and Collaborators
Aparecida Maria Catai
Investigators
Principal Investigator: Aparecida M Catai, pHD Universidade Federal de Sao Carlos
  More Information

Publications:

Responsible Party: Aparecida Maria Catai, PhD, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01889784     History of Changes
Other Study ID Numbers: 13573013.1.0000.5504
Study First Received: June 5, 2013
Last Updated: June 28, 2013
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Sao Carlos:
diabetes mellitus, type 2
phototherapy
physical exercise
oxygen consumption
arterial blood pressure
heart rate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014