Effects of trunk light therapy combined with exercise in men with Type 2 diabetes mellitus

INTERVENTION: This is a randomized, sham‐controlled, two‐arm, parallel‐group clinical trial with a 1:1 allocation ratio and blinding of participants and the researcher responsible for outcome assessment regarding group allocation. The randomization sequence will be generated using the Random.org website by means of random numbers, and allocation will be performed using sequentially numbered, opaque, sealed envelopes prepared in advance by an independent researcher who will not participate in outcome assessments or intervention delivery. After enrollment and baseline assessment, each participant will be allocated to one of the two groups according to the randomization sequence. All participants will initially undergo two weeks of familiarization with the resistance training protocol, which will not be considered part of the experimental intervention, followed by eight weeks of intervention, consisting of two supervised sessions per week, for a total of 16 sessions, with each session lasting approximately 30 minutes. The resistance training protocol will consist of 45‐degree leg press, lunge, and resisted plantar flexion exercises. Training intensity will be controlled by the relative load corresponding to 10‐repetition maximum, repetitions in reserve, and perceived exertion assessed using the Resistance Exercise Scale, also referred to as OMNI‐RES, an ordinal scale ranging from 0 to 10, with verbal descriptors and visual illustrations corresponding to the progression of perceived effort. At the end of each set, participants will indicate the value corresponding to their perceived exertion. During weeks 1 and 2 of the intervention, participants will perform three sets of 10 repetitions at 50% of the load corresponding to 10‐repetition maximum, with 6 to 8 repetitions in reserve, a 120‐second rest interval between sets, and a cadence of three seconds per repetition, consisting of two seconds during the eccentric phase and one second during the concentric phase. During weeks 3 to 6, the load will be increased to 80% of 10‐repetition maximum, with 2 to 4 repetitions in reserve, while maintaining three sets of 10 repetitions. During weeks 7 and 8, the load will be increased to 90% of 10‐repetition maximum, with 2 to 4 repetitions in reserve, while maintaining three sets of 10 repetitions and a 90‐second rest interval between sets. The load will be increased by 5% to 10% when the participant completes 10 repetitions with more than four repetitions in reserve in two consecutive sessions. In all sessions, training volume, load used, repetitions in reserve, perceived exertion assessed using the OMNI‐RES scale, and session internal load will be recorded, with session internal load calculated as the product of session duration and perceived exertion. Training will be performed at a standardized time according to each participant's medication and meal schedule, maintaining the same time window with a maximum variation of 30 minutes between sessions. Before each session, the time of the last medication intake, the time of the last meal, and capillary blood glucose wi CONDITION: C18.452.394.750 Diabetes Mellitus type 2 ; Diabetes Mellitus PRIMARY OUTCOME: Expected outcome 1: It is expected that the intervention will promote a reduction in glycated hemoglobin (HbA1c) levels, expressed as a percentage (%), over the eight‐week intervention period compared with the sham group. HbA1c will be assessed at baseline, at week 4, and after eight weeks of intervention, and changes in HbA1c values between the different assessment time points will be analyzed. A difference of approximately 0.4 percentage points in HbA1c between the groups at the end of the eight‐week intervention is expected and will be considered clinically significant SECONDARY OUTCOME: Expected outcome 2: Changes are expected in the biochemical profile comprising the lipid profile, a panel of inflammatory, hormonal, and metabolic markers, and creatine kinase (CK); cognitive function, sleep quality, and mood state assessed via the Addenbrooke's Cognitive Examination‐Revised (ACE‐R), Pittsburgh Sleep Quality Inde X(PSQI), and Diabetes Distress Scale (DDS), respectively; musculoskeletal parameters assessed by dual‐energy X‐ray absorptiometry (DEXA), musculoskeletal ultrasound, and the 10‐repetition maximum (10‐RM) test; functional capacity assessed by the Short Physical Performance Battery (SPPB); and cardiovascular and metabolic parameters including pulse wave velocity (PWV), central blood pressure, cardiac output, total peripheral vascular resistance, and metabolic flexibility assessed via cardiopulmonary exercise testing (CPET). Changes observed between the baseline and post‐intervention assessments will be compared between the intervention and sham groups to evaluate the effects of the intervention on the various domains assessed INCLUSION CRITERIA: Male participants; medical diagnosis of type 2 diabetes mellitus; diagnosis established five years ago; regular use of oral pharmacotherapy for at least si Xmonths; glycated hemoglobin between 6.5% and 8.5%; fasting blood glucose between 100 and 250 mg/dL; age between 40 and 65 years; body mass inde Xbetween 18.0 and 34.9 kg/m²; sedentary; preserved cognitive capacity