Diabetes and metabolic syndrome. Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Patients recruited to the study are assigned randomly to an exercise prescription (aerobic + strength) intervention
Control: Exercise counselling
Sponsors
Metabolic Fitness Association (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes patients with metabolic syndrome, age from 40 to 80 years, duration of diabetes >1 year, body mass index (BMI) =27, =40, sedentary for at least six months, able to walk without assistance and eligible after cardiovascular algorithm evaluation. Of these, only those who give written informed consent.
Exclusion criteria
Exclusion criteria: Patients having at least one of the following conditions will be excluded from the study: 1. A history or evidence on physical examination of significant central nervous system dysfunction (i.e. hemiparesis, myelopathy, cerebellar ataxia) 2. Significant musculoskeletal deformity (i.e. amputation, scoliosis, abnormality of range of motion [ROM]) that would prevent participation (20 mmHg for systolic or >10 mmHg for diastolic blood pressure) in response to postural change, from supine to standing 8. A history or evidence on physical examination of plantar skin pressure ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Endpoint will be to determine the numbers of patients within two groups that after 12 months achieve a % rate reduction of the following parameters: Hba1c = =?15%, Cholesterol - low density lipoprotein (LDL) = =?15%, Triglyceride = =?15%, Cholesterol - high density lipoprotein (HDL) = =+15%, Blood Pressure = =?5 mmHg x diastolic and systolic, BMI = BMI reduction =7% for patients with BMI =27, Waist =-10% | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the numbers of patients within two groups that after 12 months, achieve set standards of 1. Well-being 2. Dose/response between volume and intensity of exercise training and controllable cardiovascular risk factors 3. Impact of Exercise training on: coagulation and inflammation markers, endothelial function 4. The frequency of medication for three classes of drugs (hypolipemic, hypoglycemic, and antihypertensive therapies) 5. 10-year coronary heart disease (CHD) risk (as calculated from Framingham risk tables) 6. Cost analysis: Direct medical costs and Direct and Indirect social costs | — |
Countries
Italy
Outcome results
None listed