Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy
|ClinicalTrials.gov Identifier: NCT01300273|
Recruitment Status : Unknown
Verified September 2011 by Weijie Yuan, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Active, not recruiting
First Posted : February 21, 2011
Last Update Posted : September 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetic Nephropathy||Dietary Supplement: Compound α-Ketoacid Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 4 Study of Mechanisms of Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||July 2012|
Dietary Supplement: Compound α-Ketoacid Tablet
30 patients will be treated with a LPD containing 0.6g protein/kg BW per day and 120-125 kJ/kg BW per day and supplemented with keto-amino acids (Ketosteril®, Fresenius Kabi) at a dosage of 100 mg/kg BW per day.
- monitor podocyte loss by detecting nephrin, podocin, and synaptopodin mRNA in urine particulates with quantitative reverse transcriptase-PCR. [ Time Frame: At baseline and every 3 months ]At baseline and every 3 months, a whole-stream early morning urine specimen will be collected for gene expression study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300273
|Department of Nephrology,Shanghai Jiaotong University Affiliated First People's Hospital|
|Shanghai, Shanghai, China, 200080|
|Principal Investigator:||Weijie Yuan, Professor||Department of Nephrology, First People's Hospital, Shanghai Jiao Tong University|