Clinical trial NCT01889784: Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus
Official title: Evaluation of Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes mellitus, type 2
phototherapy
physical exercise
oxygen consumption
arterial blood pressure
heart rate
baroreflex sensitivity
cardiovascular autonomic control
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-06-28
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
timeFrame: Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
timeFrame: Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Secondary outcomes:
measure: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
timeFrame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
timeFrame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
timeFrame: Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
timeFrame: Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Other outcomes:
measure: Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
timeFrame: Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
timeFrame: Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
timeFrame: Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
timeFrame: Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
timeFrame: Change in heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
measure: Change in heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
timeFrame: Change in heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Locations:
city: São Carlos
country: Brazil
facility: Universidade Federal de São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Aparecida M Catai, pHD
role: PRINCIPAL_INVESTIGATOR
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