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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
Sponsor:
Collaborators:
Huashan Hospital
Shanghai East Hospital
Shanghai 6th People's Hospital
Information provided by (Responsible Party):
Weijie Yuan, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 18, 2011
First Posted Date  ICMJE February 21, 2011
Last Update Posted Date September 8, 2011
Study Start Date  ICMJE February 2011
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy
Official Title  ICMJE Phase 4 Study of Mechanisms of Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy
Brief Summary The investigators hypothesize that, LPD supplemented with ketoanalogs will reduce urine podocyte loss and lower the angiotensinogen level in the urine.
Detailed Description Diabetic nephropathy is one of the most important causes of end stage renal disease in the world. Recently In a multicenter, randomized clinical trial performed in China, which aimed to evaluate the efficacy and safety of compound α-keto acid tablet in combination with low protein diet (LPD+KA) in delaying the progress of type 2 diabetic nephropathy(T2DN). In that study it was found that LPD+KA was associated with amelioration of proteinuria, better reduction in the loss of kidney function compared with LPD alone meanwhile nutrition status remained well in both group(Role of Ketoanalogs in diabetic nephropathy—China study, to be submitted for publication). However, in that study the mechanisms underlined these effects were not been elucidated This research proposal is a part of the continuation of that study. Restriction of Protein intake, strictly control blood pressure, particularly using renin-angiotensin system (RAS) blockade have been shown to ameliorate proteinuria and progression of CKD. Podocyte damage has been know to play critical role for proteinuria and renal function loss A recent study showed that the mRNA expression of podocyte markers in urinary sediment is increased in patients with T2DN, and this effect can be inhibited by ACE inhibitor and ARB, which indicates the important role of local renal RAS to involve in the damage. Urinary angiotensinogen level is a good marker of the situation of renal RAS. Consequently the investigators are proposing to study the effect of LPD+KA on podocyte as well as on local RAS in the kidney.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetic Nephropathy
Intervention  ICMJE 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.
Other Names:
  • Ketosteril
  • Ketoanalogs
Study Arms  ICMJE Experimental: Ketosteril
Intervention: Dietary Supplement: Compound α-Ketoacid Tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 18, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosed with type 2 diabetes
  • age range is 18 - 80 years old
  • no gender restrictions
  • use oral hypoglycemic agents (limited to repaglinide, α-glucosidase inhibitor and chloroquine ketone) and/or insulin to control blood sugar
  • fasting blood sugar is not higher than 10mmol/l, glycated hemoglobin is not higher than 8.5%
  • using RAS system blockers (ACEI or ARB) for at least 4 weeks and blood pressure is no higher than 160/90mmHg. Once enrolled in the group, the dose should not be changed, unless there is contraindication
  • has not yet started dialysis, GFR based on simplified MDRD formula is between (15-60) ml/min/1.73m2
  • serum albumin is not less than 25g/l and appearing dominant proteinuria (urinary albumin excretion rate > 300mg/24h)
  • understanding and willing to participate in the trial and signed informed consent

Exclusion Criteria:

  • compliance is poor
  • GFR < 15ml/min/1.73m2
  • repeated hypercalcemia, hyperkalemia
  • ketoacidosis occurred in recent 6 months
  • chronic heart failure, above NYHA 3 grade
  • combined with other serious diseases in 3 months
  • obvious symptoms and signs of liver disease. Alanine or aspartate aminotransferase 2 times higher than normal
  • severe edema, or up to the level of nephrotic syndrome or that there is serous cavity effusion
  • urinary tract infections or other urinary tract diseases
  • drug abusers
  • diagnosed of malignancy
  • receiving long-term systemic steroid therapy
  • women pregnancy or Intended pregnancy and breastfeeding
  • took part in other clinical drug studies 30 days before the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01300273
Other Study ID Numbers  ICMJE KETO-011-IP4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weijie Yuan, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE
  • Huashan Hospital
  • Shanghai East Hospital
  • Shanghai 6th People's Hospital
Investigators  ICMJE
Principal Investigator: Weijie Yuan, Professor Department of Nephrology, First People's Hospital, Shanghai Jiao Tong University
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP