Preventing Renal Functional Abnormalities With Calorie Restriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk (CRESO)
The study investigates whether a caloric restricted dietary regime can prevent onset and/or progression of chronic kidney disease in type 2 diabetic patients with abdominal obesity, through the amelioration of concomitant metabolic abnormalities such as insulin resistance, dyslipidemia, hypertension and inflammation, possible risk factors for the onset of kidney disease.
The main aim of the study is therefore to evaluate the renoprotective effect of caloric restriction (CR) on subjects at risk of nephropathy. Secondary aim is to better understand how dietary implementation can modulate renal disease and its associated metabolic abnormalities.
|Diabetes Mellitus||Other: Caloric restriction Other: No intervention||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Preventing Renal Functional Abnormalities Predisposing to Chronic Kidney Disease in Abdominal Obesity: A Randomized, Parallel-Group, Pilot Study of Calorie REstriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk|
- Glomerular Filtration Rate (GFR), absolute and percent change, at 6 months vs baseline. [ Time Frame: 0 and 6 month. ]
- Renal Plasma Flow (RPF) [ Time Frame: At baseline, 3 and 6 month ]
- Filtration Fraction (FF) [ Time Frame: At baseline, 3 and 6 month ]
- Renal Vascular Resistance (RVR) [ Time Frame: At baseline, 3 and 6 month. ]
- Albuminuria [ Time Frame: At baseline, 3 and 6 month. ]
- Metabolic and inflammatory parameters. [ Time Frame: At baseline and 6 month ]
|Study Start Date:||September 2009|
|Study Completion Date:||February 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Caloric restriction
Other: Caloric restriction
Sham Comparator: Diet "ad libitum"
Diet "ad libitum"
Other: No intervention
Diet "ad libitum"
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01213212
|Clinical Research Center for Rare Diseases|
|Ranica, Bergamo, Italy, 24020|