Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus
- EligibilityCriteria: Inclusion Criteria:  age>18 years old confirmed chronic kidney disease (with eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria >500 mg/g urinary creatinine) and confirmed type 2 Diabetes Mellitus stable kidney function for at least 12 weeks before enrollment (defined as decrease in eGFR < 5 ml/min/1.73 m2/year according to KDIGO 2012 guideline) treatment with ACE/ARBs and/or MRAs for at least 3 months no previous treatment with SGLT2i good nutritional status declared and anticipated good compliance with the prescribed diet signed informed consent  Exclusion Criteria:  eGFR < 25 ml/min/1.73 m2 poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg) class IV NYHA heart failure, recent MACE (less than 6 months) relevant comorbid conditions (active infections (HBV, HCV, HIV), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy) ADPKD kidney transplantation with functional graft malnutrition: BMI<18 kg/me, eight loss >10% during the last 6 months, serum albumin <3 g/dL feeding inability (anorexia, nausea) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult