Study to Weigh the Effect of Exercise Training on BONE (SWEET-BONE) Quality and Strength in Type 2 Diabetes

Prior treatment

• treatment with anti-fracturative agents, estrogens, aromatase inhibitors, testosterone, corticosteroids and/or glitazon;
• previous documented non-traumatic fractures,

Other illness

• any condition limiting participation in a clinical trial, including psychiatric disorders or hospitalization for depression in the past 6 months;
• any condition limiting PA/exercise, including musculoskeletal disorders or deformities, central nervous system dysfunction such as hemiparesis, myelopathies, cerebral ataxia, vestibular dysfunction, and postural hypotension (i.e. a fall of \>20 mmHg of systolic or \>10 mmHg of diastolic blood pressure when changing position);
• cancer and other life-expectancy limiting conditions;
• recent major acute cardiovascular event, including heart attack, stroke/transient ischemic attack(s), revascularization procedure, or participation in a cardiac rehabilitation program within the past three months, or documented history of pulmonary embolism in the past six months;
• diabetic foot with history of ulcer;

Lab values

• macroalbuminuria and/or estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2;
• hemoglobin (Hb) A1c \>9.0%;
• a T score \<-2.5 at spine/hip at dual-energy X-ray absorptiometry (DXA). Subjects with HbA1c or blood pressure above the indicated threshold will be receive appropriate treatment and will be re-evaluated after 3 months. Patients with vitamin D levels \< 10 ng/dl will be treated with cholecalciferol 25.000 IU/week for 6 weeks and will be re-evaluated for eligibility 2 weeks after the last

Other

• pre-proliferative and proliferative retinopathy;
• ankle/brachial index (ABI) \<0.9;
• severe motor and sensory neuropathy;
• blood pressure (BP) \>150/90 mmHg;
• vitamin D \<10 ng/ml;
• total spine deformity index (SDI) \>3 (and \>1 in a single vertebra);

• diabetes duration \>5-year
• sedentary lifestyle (i.e. more than 8 hours/day spent in any waking behavior characterized by an energy expenditure ≤1.5 metabolic equivalents \[METs\] while in a sitting or reclining posture) from at least 6 months;
• physically inactivity (i.e. insufficient amounts of physical activity \[PA\] according to current guidelines) from at least 6 months;
• body mass index (BMI) 27-40 kg/m2;
• ability to walk 1.6 Km without assistance;
• a Short Battery Performance Test score ranging from 4 to 9;
• eligibility after cardiologic evaluation.