Diabetes mellitus, Type 2
Conditions
Interventions
This is a randomized, double-blind, sham-controlled clinical trial. The randomization process will be performed using the website randomization.com, with participants allocated into four groups of 10
G2 – effective whole-body photobiomodulation for 20 minutes (10 minutes in the anterior body region and 10 minutes in the posterior body region) associated with 10 minutes of sham
G3 – effective whole-body photobiomodulation for 30 minutes (15 minutes in the anterior body region and 15 minutes in the posterior body region)
G4 – sham for 30 minutes (15 minutes in the anterior body region and 15 minutes in the posterior body region). In the second week, participants will attend in a fasting state, with oral hypoglycemic a
Sponsors
Departamento de Fisioterapia
Departamento de Fisioterapia
Eligibility
Sex/Gender
Male
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Study participants must be male; between 40 and 70 years old; with a low level of physical activity (according to the International Physical Activity Questionnaire (IPAQ) classification); BMI up to 34.9 kg/m² (grade I obesity); body fat percentage =45% estimated using the Durnin and Womersley equations and converted using Siri analysis.; medical diagnosis of DM2 for at least 5 years; regular use of oral hypoglycemic medication for at least 6 months
Exclusion criteria
Exclusion criteria: Participants with fasting capillary blood glucose >200 mg/dL; alcoholics; drug addicts; insulin-dependent individuals; heart patients using pacemakers; those with any cognitive deficit; neurological or pulmonary disease; and those diagnosed with any type of cancer undergoing treatment will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: A reduction in postprandial plasma glucose is expected in men with type 2 diabetes mellitus undergoing whole-body photobiomodulation (WBP) at different irradiation doses, verified through serial capillary blood glucose monitoring at pre-prandial, post-prandial, and 1h, 3h, 6h, 12h, and 24h post-intervention times using a portable glucometer, based on the observation of glycemic reductions greater than those observed in the sham group.;Finding Outcome 1: A significant reduction in postprandial plasma glucose was observed in the groups undergoing whole-body photobiomodulation, especially in the 10- and 30-minute protocols, verified through serial capillary blood glucose monitoring at pre-prandial, post-prandial, and 1h, 3h, 6h, 12h, and 24h post-intervention times using a portable glucometer. The greatest reductions in blood glucose levels occurred mainly 1 hour and 3 hours after the intervention, when compared to the sham group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 2: A time-response effect of whole-body photobiomodulation on plasma glucose in men with type 2 diabetes mellitus is expected, verified by analyzing glycemic variation and the area under the curve (AUC) during 24 hours after a single intervention, using one-way ANOVA statistical analysis and calculating the area under the curve, based on the observation of partial maintenance of glycemic reduction throughout the monitoring period.;Finding Outcome 2: A time-response effect of whole-body photobiomodulation on plasma glucose in men with type 2 diabetes mellitus was observed, verified by analyzing glycemic variation and the area under the curve (AUC) during 24 hours after a single intervention. The results demonstrated partial maintenance of glycemic reduction up to 12 hours after the intervention, especially in the groups subjected to the 10- and 30-minute PBM protocols, with no statistically significant differences in the 6-hour and 24-hour assessments when compared to the sham group. | — |
Countries
BR
Contacts
Public ContactFrancisco da Rocha
Universidade Federal de São Carlos
Outcome results
None listed