exercise
Conditions
Interventions
This randomized, triple-blind clinical trial will include 39 men with type 2 diabetes mellitus (T2DM), aged 65-79 years, with a body mass index (BMI) of 22-32 kg/m², randomly assigned to three groups:
G07.203.300.456
Sponsors
Universidade São Judas Tadeu
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Sex/Gender
Male
Age
65 Years to 79 Years
Inclusion criteria
Inclusion criteria: Diabetes Mellitus type 2 (DMT2) with a stable medication dose (oral antidiabetics, insulin, or a combination of both) for three or more months; glycated hemoglobin between 6% and 9.0%; renal function assessed by the Modification of Diet in Renal Disease (MDRD) above 60 ml/h; no untreated or decompensated chronic non-communicable disease; male sex; age between 65 and 79 years
Exclusion criteria
Exclusion criteria: Inability to undergo assessments and reassessments; having more than three absences during the training period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in muscle strength, measured by isokinetic knee assessment (in Joules) and handgrip strength (in kg/f), as well as an improvement in the glycemic profile, assessed through biochemical analysis of glucose (mg/dL), fructosamine (µmol/L), glycated hemoglobin (%), insulin (µU/mL), homeostatic model assessment for insulin resistance (HOMA-IR), and C-peptide (ng/mL) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression of muscle strength measured by one-repetition maximum, muscle thickness (mm), body composition: lean mass (kg) and fat mass (kg and %); lipid profile measured by biochemical analysis: low-density lipoprotein (LDL) (mg/dL), high-density lipoprotein (HDL)(mg/dL),very low-density lipoprotein (VLDL) (mg/dL), triglycerides (mg/dL), cholesterol (mg/dL); hormonal profile: total testosterone (ng/dL),free testosterone (pmol/L), and sex hormone-binding globulin (SHBG) (nmol/L); dietary intake (protein, lipids, and fat); functional performance – short physical performance battery (SPPB) test scores, which range from 1 to 12 points, including balance test, gait test (s), and sit-to-stand test (s); postural balance assessment, dynamic postural balance test measured by Mini balance evaluation systems test (MiniBESTest), which consists of four sections: postural responses, anticipatory postural adjustments, sensory orientation, and dynamic balance during locomotion. Scores range from 0 to 2 for each item, with a maximum of 28; balance test, gait test (s), sit-to-stand test (s), and the time up go (TUG )test with and without a cognitive task (measured in second). | — |
Countries
Brazil
Contacts
Public ContactAngelica Alonso
Universidade São Judas Tadeu
Outcome results
None listed