Effects of Caloric Restriction in Obesity and Type 2 Diabetes

Inclusion criteria

• Age >40 years;
• Type 2 diabetes (ADA criteria);
• UAE <300 mg/24h;
• Body mass index (BMI)>27kg/m2;
• Serum creatinine < 1.2 mg/dL;
• No major changes in calorie, protein and sodium intake in the last 6 mos;
• No major changes in concomitant treatments with blood pressure, glucose or lipid lowering agents since 6 and 3 months respectively;
• Patients legally able to give written informed consent to the trial (signed and dated by the patient);
• Written informed consent.

Exclusion criteria

• Concomitant non-diabetic renal disease or ischemic kidney disease;
• Primary or immune-mediated renal disease;
• Urinary tract obstruction or infection;
• Treatment with steroids and/or non-steroid anti-inflammatory agents;
• Treatment with thiazide or loop diuretics that, on the basis of the Investigator's judgment, might sustain hypovolemia and/or sodium depletion (with secondary kidney hypoperfusion/hypofiltration);
• Hearth failure and/or hemodynamically significant left ventricular systolic dysfunction, cirrhosis, uncontrolled hyperglycemia resulting in glycosuria, hyper/hyponatremia of any cause;
• Previous surgical procedures for weight loss;
• Previous episodes of depression, or suicide attempts;
• Chronic abuse of alcohol and drugs;
• Pregnancy, ineffective contraception or peri-menopausal age;
• Cancer or any chronic disease that might affect the completion of the study;
• Chronic obstructive pulmonary disease (COPD) in treatment with positive airway pressure;
• Unwillingness or inability to adhere to CR intervention over the entire 24-months intervention period;
• Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
• Evidence of an uncooperative attitude;
• Any evidence that patient will not be able to complete the trial follow-up;
• Inability to fully understand the potential risks and benefits of the study.