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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

Study Description
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Brief Summary:
The investigators hypothesize that, LPD supplemented with ketoanalogs will reduce urine podocyte loss and lower the angiotensinogen level in the urine.

Condition or disease Intervention/treatment Phase
Type 2 Diabetic Nephropathy Dietary Supplement: Compound α-Ketoacid Tablet Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketosteril 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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


Locations
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China, Shanghai
Department of Nephrology,Shanghai Jiaotong University Affiliated First People's Hospital
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Huashan Hospital
Shanghai East Hospital
Shanghai 6th People's Hospital
Investigators
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Principal Investigator: Weijie Yuan, Professor Department of Nephrology, First People's Hospital, Shanghai Jiao Tong University
More Information
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Publications:

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Responsible Party: Weijie Yuan, Chief physician, Director of Department of Nephrology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01300273    
Other Study ID Numbers: KETO-011-IP4
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Keywords provided by Weijie Yuan, Shanghai Jiao Tong University School of Medicine:
Diabetic nephropathy
Podocyte
Low Protein Diet
Ketoanalogs
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Proteinuria
Urologic Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
Urological Manifestations