The study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation. The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on subjects at risk of nephropathy. Secondary aims are to better understand the relationship between CR and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
103
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy
The percent change in glomerular filtration rate (GFR) at month 6 versus baseline and the rate of GFR decline from month 6 to study end
Time frame: At baseline, 6, 12 and 24 month
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