Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy
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|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.
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): 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|