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

September 6, 2011 updated by: Weijie Yuan, Shanghai Jiao Tong University School of Medicine

Phase 4 Study of Mechanisms of Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Department of Nephrology,Shanghai Jiaotong University Affiliated First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Huashan Hospital
Shanghai East Hospital
Shanghai 6th People's Hospital

Investigators

  • Principal Investigator: Weijie Yuan, Professor, Department of Nephrology, First People's Hospital, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

September 8, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KETO-011-IP4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetic Nephropathy

Clinical Trials on Compound α-Ketoacid Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe