Effects of Caloric Restriction in Obesity and Type 2 Diabetes (CRESO2)
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.
|Type 2 Diabetes Obesity||Behavioral: Calorie restriction (25%) Behavioral: Ad libitum health diet|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
|Official Title:||LONG-TERM EFFECTS OF CALORIC RESTRICTION ON METABOLIC, RENAL AND RETINAL HEALTH IN SUBJECTS AFFECTED BY OBESITY AND TYPE 2 DIABETES|
- 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 ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Calorie restriction (25%)
CR will correspond to a reduction of 25% from the total daily calorie expenditure calculated as Total Daily Energy Expenditure (TDEE) (kcal/d) using the formula from the validated Seven-Day Physical Activity Recall (PAR) Questionnaire (RMR x activity levels).
|Behavioral: Calorie restriction (25%)|
|Active Comparator: Ad libitum health diet||Behavioral: Ad libitum health diet|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01930136
|Clinical Research Center for Rare Diseases|
|Ranica, Bergamo, Italy, 24020|