Preventing Renal Functional Abnormalities With Calorie Restriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk (CRESO)
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|ClinicalTrials.gov Identifier: NCT01213212|
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : February 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Caloric restriction Other: No intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||February 2013|
Experimental: Caloric restriction
Other: Caloric restriction
Sham Comparator: Diet "ad libitum"
Diet "ad libitum"
Other: No intervention
Diet "ad libitum"
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213212
|Clinical Research Center for Rare Diseases|
|Ranica, Bergamo, Italy, 24020|